Skip to the page
Get started – free

Data / Medical devices / Germany / Roche Diagnostics GMBH

Roche Diagnostics GMBH: FDA-registered device maker in MANNHEIM Baden-Wurttemberg, Germany, 307 510(k) clearances and 22 PMA approvals

Roche Diagnostics GMBH is registered with the FDA (registration 9610126) in MANNHEIM Baden-Wurttemberg, Germany. It lists 273 device types. The FDA files 307 510(k) clearances and 22 PMA approvals under its listings, the newest dated October 20, 2026. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Roche Diagnostics GMBH
FDA registration number
9610126
FEI number
3002806559
Address
Sandhofer Strasse 116, MANNHEIM Baden-Wurttemberg, Germany, D-68305
Owner or operator
Roche Diagnostics Operations Inc. (9039767)
Roles
Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
June 1, 1983
Registered through
2027
Brand names listed
10X SSC, 579-2-RSA Dynamic Interface v1.1, 713-2-cobase 8100 v1.5, 770-1-CCM-AOB v1.1, ?-Amylase EPS ver.2, ?-Glutamyltransferase ver.2 - Standardized against IFCC / Szasz, ?-Glutamyltransferase ver.2-Standardized against IFCC/Szasz, A/C Inform II Base Unit Kit and more

Devices it lists

DeviceProduct codeClassRoleSource
25-Oh-Vitamin D Mass Spectrometry Test SystemPSL2Manufactureraccessdata.fda.gov
Abnormal Hemoglobin QuantitationGKA2Exporter to the USaccessdata.fda.gov
Acid HematinGGF2Exporter to the USaccessdata.fda.gov
Acid Phosphatase, Disodium PhenylphosphateCJX2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Acid, Folic, RadioimmunoassayCGN2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Acid, Lactic, Enzymatic MethodKHP1Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)KNK1Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Agent, ClearingKEM1Exporter to the USaccessdata.fda.gov
Albumin, Antigen, Antiserum, ControlDCF2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme MethodDIC2Exporter to the US, Manufactureraccessdata.fda.gov
Alkaline Picrate, Colorimetry, CreatinineCGX2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, ControlLKL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Alpha-1-Antitrypsin, Antigen, Antiserum, ControlDEM2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Alpha-1-Lipoprotein, Antigen, Antiserum, ControlDER2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Alpha-2-Macroglobulin, Antigen, Antiserum, ControlDEB2Exporter to the USaccessdata.fda.gov
Alzheimer’S Disease Pathology Assessment TestQSE2Manufactureraccessdata.fda.gov
Amikacin Serum AssayKLP2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Analyzer, Chemistry, Micro, For Clinical UseJJF1Exporter to the US, Manufactureraccessdata.fda.gov
Anti-Müllerian Hormone Test SystemPQO2Manufactureraccessdata.fda.gov
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)NHX2Manufactureraccessdata.fda.gov
Antigen, Inflammatory Response Marker, SepsisNTM2Manufactureraccessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O ReagentGTQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Arterial Blood Sampling KitCBT1Exporter to the USaccessdata.fda.gov
Assay, CarboxyhemoglobinGHS2Exporter to the USaccessdata.fda.gov
Assay, Enzyme Linked Immunosorbent, Hepatitis C VirusMZO2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Assay, Glycosylated HemoglobinLCP2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C VirusMZP2Exporter to the USaccessdata.fda.gov
Assay, Porphyrin, Spectrophotometry, LithiumNDW2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Assayed Quality Control Material For Clinical Microbiology AssaysQCH2Manufactureraccessdata.fda.gov
Automated Urinalysis SystemKQO1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Exporter to the US, Manufactureraccessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test SystemMQM1Manufactureraccessdata.fda.gov
Biuret (Colorimetric), Total ProteinCEK2Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Exporter to the US, Manufactureraccessdata.fda.gov
Bromcresol Green Dye-Binding, AlbuminCIX2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Bromcresol Purple Dye-Binding, AlbuminCJW2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And ControlDCK2Manufactureraccessdata.fda.gov
C. Difficile Toxin Gene Amplification AssayOZN2Exporter to the USaccessdata.fda.gov
Calculator/Data Processing Module, For Clinical UseJQP1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Calibrator For Hemoglobin And Hematocrit MeasurementKRZ2Manufactureraccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Calibrator, PrimaryJIS2Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Calibrator, SecondaryJIT2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Calibrators, Drug MixtureDKB2Exporter to the US, Manufactureraccessdata.fda.gov
Calibrators, Drug SpecificDLJ2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Cardiac C-Reactive Protein, Antigen, Antiserum, And ControlNQD2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Catalytic Methods, AmylaseJFJ2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Clinical Sample ConcentratorJJH1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Colorimetric Method, Cpk Or IsoenzymesJHY2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Colorimetric Method, Gamma-Glutamyl TranspeptidaseJPZ1Manufactureraccessdata.fda.gov
Colorimetry, AcetaminophenLDP2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Colorimetry, CholinesteraseDIH1Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Colorimetry, SalicylateDKJ2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Column Chromatography & Color Development, HydroxyprolineJMM1Manufactureraccessdata.fda.gov
Columns, Liquid ChromatographyDPM1Specification developeraccessdata.fda.gov
Complement C3, Antigen, Antiserum, ControlCZW2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Complement C4, Antigen, Antiserum, ControlDBI2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Coronavirus Antigen Detection Test System.QKPNManufactureraccessdata.fda.gov
Cresolphthalein Complexone, CalciumCIC2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
CyclosporineMKW2Repackager or relabeleraccessdata.fda.gov
Cytokeratin Fragments 21-1 Eia KitOVK2Manufactureraccessdata.fda.gov
Cytomegalovirus (Cmv) Dna Quantitative AssayPAB2Exporter to the USaccessdata.fda.gov
Data Acquisition SoftwarePQQ2Exporter to the USaccessdata.fda.gov
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical SpecimensPMT2Manufactureraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Exporter to the US, Manufactureraccessdata.fda.gov
Diazo Colorimetry, BilirubinCIG2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Exporter to the US, Manufactureraccessdata.fda.gov
Differential Rate Kinetic Method, Cpk Or IsoenzymesJHS2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Dna Probe, Nucleic Acid Amplification, ChlamydiaMKZ1Exporter to the US, Manufactureraccessdata.fda.gov
Dna-Reagents, NeisseriaLSL2Exporter to the US, Manufactureraccessdata.fda.gov
Drug Mixture Control MaterialsDIF1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Drug Specific Control MaterialsLAS1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Exporter to the US, Manufactureraccessdata.fda.gov
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhCHL2Exporter to the USaccessdata.fda.gov
Electrode, Ion Specific, CalciumJFP2Exporter to the USaccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Electrode, Ion Specific, Urea NitrogenCDS2Exporter to the USaccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzymatic Method, AmmoniaJIF1Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzymatic Method, CreatinineJFY2Manufactureraccessdata.fda.gov
Enzymatic, Carbon-DioxideKHS2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Controls (Assayed And Unassayed)JJT1Manufactureraccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, CarbamazepineKLT2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, CocaineJXO2Exporter to the US, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, Cortisol, SalivaryNHG2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, DigitoxinLFM2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, DigoxinKXT2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, DiphenylhydantoinDIP2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, LidocaineKLR2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, MethotrexateLAOUManufactureraccessdata.fda.gov
Enzyme Immunoassay, N-AcetylprocainamideLAN2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total ThyroxineKLI2Exporter to the US, Manufactureraccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUExporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, PhenobarbitalDLZ2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, ProcainamideLAR2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, PropoxypheneJXN2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, QuinidineLBZ2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, TheophyllineKLS2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Immunoassay, TracrolimusMLM2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Valproic AcidLEG2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, CytomegalovirusLFZ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, RubellaLFX2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiLGD2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorption Assay, Treponema PallidumLIP2Manufactureraccessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1MXJ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2MYF2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Ferritin, Antigen, Antiserum, ControlDBF2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding CapacityJMO1Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Fibrin Split ProductsGHH2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlDAP2Repackager or relabeleraccessdata.fda.gov
Flame Photometry, LithiumJIH2Exporter to the USaccessdata.fda.gov
Fluorescence Polarization Immunoassay, AmibacinLGJ2Manufactureraccessdata.fda.gov
Fluorescence Polarization Immunoassay, CarbamazepineLGI2Exporter to the US, Manufactureraccessdata.fda.gov
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)MOJ2Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Fluorescence Polarization Immunoassay, PhenobarbitalLGQ2Exporter to the US, Manufactureraccessdata.fda.gov
Fluorescence Polarization Immunoassay, TheophyllineLGS2Exporter to the US, Manufactureraccessdata.fda.gov
Fluorescence Polarization Immunoassay, TobramycinLFW2Manufactureraccessdata.fda.gov
Fluorescent Immunoassay GentamicinLCQ2Manufactureraccessdata.fda.gov
Fluorescent Immunoassay, PrimidoneLFT2Manufactureraccessdata.fda.gov
Fluorometric, CortisolJFT2Manufactureraccessdata.fda.gov
Fructose-1, 6-Diphosphate And Nadh (U.V.), AldolaseCJC1Manufactureraccessdata.fda.gov
Gamma Globulin, Antigen, Antiserum, ControlDAH2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gas Chromatography, MethamphetamineLAF2Manufactureraccessdata.fda.gov
General Purpose ReagentPPM1Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Glucose Dehydrogenase, GlucoseLFR2Manufactureraccessdata.fda.gov
Glucose Oxidase, GlucoseCGA2Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification SystemPGX2Exporter to the USaccessdata.fda.gov
Haptoglobin, Antigen, Antiserum, ControlDAD2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Hemoglobin A1c Test SystemPDJ2Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Hepatitis A Test (Antibody And Igm Antibody)LOL2Manufactureraccessdata.fda.gov
Hepatitis Viral B Dna DetectionMKT2Exporter to the US, Manufactureraccessdata.fda.gov
Herpes Simplex Virus Nucleic Acid Amplification AssayOQO2Exporter to the USaccessdata.fda.gov
Hexokinase, GlucoseCFR2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Iga, Antigen, Antiserum, ControlCZP2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Igg, Antigen, Antiserum, ControlDEW2Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Igm (Mu Chain Specific), Antigen, Antiserum, ControlDAO2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Immunoassay Blood Test For Amyloid Pathology AssessmentSET2Manufactureraccessdata.fda.gov
Immunoassay Method, Troponin SubunitMMI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Immunochemical, CeruloplasminCHN2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Immunohistochemistry Reagents And KitsNJT1Exporter to the USaccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Exporter to the US, Manufactureraccessdata.fda.gov
Influenza A And Influenza B Multiplex Nucleic Acid AssayOZE2Exporter to the USaccessdata.fda.gov
Instrument, Hematocrit, AutomatedGKF2Exporter to the USaccessdata.fda.gov
Instrumentation For Clinical Multiplex Test SystemsNSU2Exporter to the USaccessdata.fda.gov
Interleukin 6QLCNManufactureraccessdata.fda.gov
Kinetic Method, Gamma-Glutamyl TranspeptidaseJQB1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Kit, Dna Detection, Human PapillomavirusMAQ3Exporter to the USaccessdata.fda.gov
Kit, Test,Alpha-Fetoprotein For Testicular CancerLOJ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, HdlLBS1Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Ldl & Vldl Precipitation, HdlLBR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesCDT1Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Lipase-Esterase, Enzymatic, Photometric, LipaseCHI1Manufactureraccessdata.fda.gov
Lipoprotein X, Antigen, Antiserum, ControlDEL1Exporter to the US, Manufactureraccessdata.fda.gov
Lipoprotein, Low-Density, Antigen, Antiserum, ControlDFC2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Mass Spectrometer, Clinical UseDOP1Specification developeraccessdata.fda.gov
Medical Device Data SystemOUG1Manufacturer, Specification developeraccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Method, Nephelometric, Immunoglobulins (G, A, M)CFN2Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Monitor, Microbial GrowthJTA1Manufactureraccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Mycophenolic Acid Test SystemOAV2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Myoglobin, Antigen, Antiserum, ControlDDR2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate DehydrogenaseCFJ2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Nad-Nadh, Specific Reagent For Alcohol Enzyme MethodDML2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/SgptCKA1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/SgotCIT2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
NephelometerJZW1Exporter to the US, Manufactureraccessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesCJE2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Exporter to the US, Manufactureraccessdata.fda.gov
Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) DnaQLX2Exporter to the USaccessdata.fda.gov
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted InfectionsQEP2Manufactureraccessdata.fda.gov
Olive Oil Emulsion (Turbidimetric), LipaseCET1Exporter to the US, Manufactureraccessdata.fda.gov
Oximeter To Measure HemoglobinGLY2Exporter to the USaccessdata.fda.gov
OxyhemoglobinGGZ2Exporter to the USaccessdata.fda.gov
Ph BufferJCC1Exporter to the USaccessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic PhosphorusCEO1Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Photometric Method, Iron (Non-Heme)JIY1Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Photometric Method, MagnesiumJGJ1Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Plasma, Coagulation ControlGGN2Manufactureraccessdata.fda.gov
Prealbumin, Antigen, Antiserum, ControlJZJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Procalcitonin AssayPRI2Manufactureraccessdata.fda.gov
Prognostic Test For Development Or Progression Of PreeclampsiaQWH2Manufactureraccessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate CancersLTJ2Manufactureraccessdata.fda.gov
Pump, Infusion, InsulinLZG2Specification developeraccessdata.fda.gov
Qualitative And Quantitative Hepatitis B Virus Antibody AssaysSEI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Radioassay, Triiodothyronine UptakeKHQ2Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Radioassay, Vitamin B12CDD2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay (Two-Site Solid Phase), FerritinJMG2Manufactureraccessdata.fda.gov
Radioimmunoassay, 17-HydroxyprogesteroneJLX1Manufactureraccessdata.fda.gov
Radioimmunoassay, ActhCKG2Manufactureraccessdata.fda.gov
Radioimmunoassay, AndrostenedioneCIZ1Manufactureraccessdata.fda.gov
Radioimmunoassay, C-Peptides Of ProinsulinJKD1Manufactureraccessdata.fda.gov
Radioimmunoassay, CalcitoninJKR2Manufactureraccessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)JKC1Manufactureraccessdata.fda.gov
Radioimmunoassay, EstradiolCHP1Manufactureraccessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating HormoneCGJ1Manufactureraccessdata.fda.gov
Radioimmunoassay, Free ThyroxineCEC2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Human Growth HormoneCFL1Manufactureraccessdata.fda.gov
Radioimmunoassay, Immunoglobulins (D, E)JHR2Manufactureraccessdata.fda.gov
Radioimmunoassay, Immunoreactive InsulinCFP1Manufactureraccessdata.fda.gov
Radioimmunoassay, Lsd (125-I)DLB2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Radioimmunoassay, Luteinizing HormoneCEP1Manufactureraccessdata.fda.gov
Radioimmunoassay, MethaqualoneKXS2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Radioimmunoassay, Parathyroid HormoneCEW2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, ProgesteroneJLS1Manufactureraccessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)CFT1Manufactureraccessdata.fda.gov
Radioimmunoassay, Testosterones And DihydrotestosteroneCDZ1Manufactureraccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Radioimmunoassay, TobramycinKLB2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Radioimmunoassay, Total ThyroxineCDX2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Total TriiodothyronineCDP2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, VancomycinLEH2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Reagent, Coronavirus SerologicalQKONExporter to the US, Manufactureraccessdata.fda.gov
Reagent, Occult BloodKHE2Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic AcidQJRNExporter to the USaccessdata.fda.gov
Real Time Nucleic Acid Amplification SystemOOI2Exporter to the US, Manufactureraccessdata.fda.gov
Refractometer For Clinical UseJRE1Exporter to the US, Manufactureraccessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay SystemOCC2Exporter to the USaccessdata.fda.gov
SJMSJMManufactureraccessdata.fda.gov
Sars-Cov-2 Serology TestQVP2Manufactureraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Somatic Gene Mutation Detection SystemOWD3Exporter to the USaccessdata.fda.gov
Station, Pipetting And Diluting, For Clinical UseJQW1Exporter to the USaccessdata.fda.gov
System, Hemoglobin, AutomatedGKR2Exporter to the USaccessdata.fda.gov
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct SpecimenNQX2Exporter to the USaccessdata.fda.gov
System, Test, Beta-2-Microglobulin ImmunologicalJZG2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
System, Test, Blood Glucose, Over The CounterNBW2Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, Test, C-Reactive ProteinDCN2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic CancerNIG2Manufactureraccessdata.fda.gov
System, Test, Carcinoembryonic AntigenDHX2Manufactureraccessdata.fda.gov
System, Test, Human Chorionic GonadotropinDHA2Manufactureraccessdata.fda.gov
System, Test, Immunological, Antigen, TumorMOI2Manufactureraccessdata.fda.gov
System, Test, Low Density, LipoproteinMRR1Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
System, Test, OsteocalcinNEO2Manufactureraccessdata.fda.gov
System, Test, Rheumatoid FactorDHR2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
System, Test, ThyroglobulinMSW2Manufactureraccessdata.fda.gov
System, Test, Thyroid AutoantibodyJZO2Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, Test, Urinary Methylmalonic AcidLPT2Exporter to the US, Manufactureraccessdata.fda.gov
System, Test, Vitamin DMRG2Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, Transport, AerobicJTW1Exporter to the USaccessdata.fda.gov
Test, Cystatin CNDY2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Test, Donor, CmvMZE2Manufactureraccessdata.fda.gov
Test, Donor, Syphilis, Antigens, TreponemalMYR2Manufactureraccessdata.fda.gov
Test, Epithelial Ovarian Tumor Associated Antigen (He4)OIU2Manufactureraccessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)LTK2Manufactureraccessdata.fda.gov
Test, Equipment, Automated Bloodborne PathogenMZANExporter to the USaccessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Test, Hiv DetectionMZF2Exporter to the US, Manufactureraccessdata.fda.gov
Test, Natriuretic PeptideNBC2Manufactureraccessdata.fda.gov
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign ConditionsMTG3Manufactureraccessdata.fda.gov
Test, Time, ProthrombinGJS2Manufactureraccessdata.fda.gov
Test, Urine LeukocyteLJX1Exporter to the US, Manufactureraccessdata.fda.gov
Titrimetric With Edta And Indicator, CalciumCHW2Manufactureraccessdata.fda.gov
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate CancerMTF3Manufactureraccessdata.fda.gov
Transferrin, Antigen, Antiserum, ControlDDG2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Tube, Collection, Capillary BloodGIO1Exporter to the USaccessdata.fda.gov
Turbidimetric Method, LipoproteinsJHN1Exporter to the US, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)JIQ1Manufactureraccessdata.fda.gov
Turbidimetric, Total ProteinJGQ2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea NitrogenCDQ2Exporter to the US, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test SystemLPS2Manufactureraccessdata.fda.gov
Whole Blood Hemoglobin DeterminationKHG2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 307.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 20, 2026DEN260027Elecsys HBsAg II quant II RxDxSJMUnknownRoche Diagnosticsaccessdata.fda.gov
August 19, 2026K261686Elecsys Phospho-Tau (217P) PlasmaSETSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
April 24, 2026K252431Elecsys CalcitoninJKRSubstantially EquivalentRoche Diagnostics GmbHaccessdata.fda.gov
April 13, 2026K252280Elecsys Anti-SARS-CoV-2 SQVPSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
April 7, 2026K260049Elecsys Anti-HBc IgMSEISubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
April 7, 2026K260048Elecsys Anti-HAV IgMLOLSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
April 7, 2026K260046Elecsys Anti-HBc IISEISubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
April 2, 2026K260026Tina-quant Cardiac high sensitivity CRP IIINQDSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
December 17, 2025K253839Elecsys Anti-SARS-CoV-2QVPSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
October 24, 2025K253188CoaguChek XS Plus SystemGJSSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
October 8, 2025K252163Elecsys Phospho-Tau (181P) PlasmaSETSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
July 17, 2025K242505Elecsys Cortisol IIIJFTSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
June 10, 2025K250768Elecsys Anti-SARS-CoV-2QVPSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
February 7, 2025K241453Elecsys sFlt-1 and Elecsys PlGFQWHSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
January 24, 2025K241220Tina-quant Lipoprotein(a) Gen.2 MolarityDFCSubstantially EquivalentRoche Diagnostics Operationsaccessdata.fda.gov
January 16, 2025K240197cobas® liat CT/NG/MG nucleic acid testQEPSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
March 22, 2024K231927Elecsys PTH , Elecsys PTH STATCEWSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
February 20, 2024K233454ONLINE TDM MethotrexateLAOSubstantially EquivalentRoche Diagnostics Operationsaccessdata.fda.gov
September 30, 2023K221890Elecsys Tg IIMSWSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
September 15, 2023K222610Elecsys Anti-TgJZOSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
July 21, 2023K223637Elecsys proBNP II, Elecsys proBNP II STATNBCSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
June 5, 2023K231348Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFQSESubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
April 7, 2023K220456Elecsys FT4 IVCECSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
March 30, 2023K230161ONLINE TDM Phenytoin - Free Phenytoin applicationMOJSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
January 4, 2023K221693Elecsys Anti-HCV II (08837031190)MZOSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
December 23, 2022K221765ONLINE DAT Benzodiazepines IIJXMSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
December 7, 2022K221842Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSFQSESubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
October 12, 2022K220924Elecsys HSV-2 IgG (08948887160)MYFSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
October 12, 2022K220923Elecsys HSV-1 IgG (08948844160)MXJSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
October 12, 2022K220911Elecsys CMV IgGLFZSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
September 15, 2022K220176Elecsys AFPLOJSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
June 10, 2022K203757Elecsys AMHPQOSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
May 6, 2022K211685Elecsys Testosterone IICDZSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
March 31, 2022K210546Elecsys proBNP II, Elecsys proBNP II STATNBCSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
September 21, 2021K201441Elecsys Troponin T Gen 5MMISubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
September 1, 2021K210901Elecsys Vitamin D total IIIMRGSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
August 18, 2021K203227Elecsys HCG STATDHASubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
July 20, 2021K211302Elecsys SyphilisLIPSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
July 30, 2020DEN200015cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitQLXUnknownRoche Molecular Systems, Inc.accessdata.fda.gov
March 26, 2020K193053Tina-quant Hemoglobin A1cDx Gen.3PDJSubstantially EquivalentRoche Diagnostics Operations (Rdo)accessdata.fda.gov
March 9, 2020K192815Elecsys BRAHMS PCTPRISubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
February 27, 2020K193313Elecsys Anti-TSHRJZOSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
February 21, 2020K192072Tina-quant C-Reactive Protein IVDCNSubstantially EquivalentRoche Diagnostics Operations (Rdo)accessdata.fda.gov
August 16, 2019K191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsCFRSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
August 13, 2019K190428Elecsys Anti-HAV IILOLSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
May 7, 2019K183432cobas u 601 urinalysis test systemJILSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
April 16, 2019K190773Elecsys TSHJLWSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
February 8, 2019K183517Ammonia IIJIFSubstantially EquivalentRoche Diagnostics Operations (Rdo)accessdata.fda.gov
November 6, 2018K173857Elecsys TacrolimusMLMSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
November 5, 2018K182095Tina-quant Transferrin ver.2 (urine application)DDGSubstantially EquivalentRoche Diagnostics Operations (Rdo)accessdata.fda.gov
July 6, 2018K173927Elecsys BRAHMS PCTPRISubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
June 22, 2018K181492Elecsys CA 15-3 IIMOISubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
April 19, 2018K180693CoaguChek XS Pro SystemGJSSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
April 19, 2018K180684CoaguChek XS Plus SystemGJSSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
March 21, 2018K173887cobas CT/NG for use on cobas 6800/8800 systemsLSLSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
February 20, 2018K171605Elecsys CA 15-3 IIMOISubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
December 25, 2017K170960CoaguChek Vantus SystemGJSSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
September 12, 2017K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemOZNSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
June 26, 2017K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) CalibratorsDJRSubstantially EquivalentLin-Zhi International, Inc.accessdata.fda.gov
June 23, 2017K162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlLGDSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
April 4, 2017K170678Beta-CrossLaps CalCheck 5JJXSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
March 17, 2017K163569Elecsys CMV IgMLFZSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
February 8, 2017K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5MRGSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
January 23, 2017K162606Elecsys TSH assay, cobas e 801 Immunoassay analyzerJLWSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
January 18, 2017K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5MMISubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
January 12, 2017K162173Elecsys CYFRA 21-1 CalCheck 5JJXSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
December 19, 2016K160571cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 AssayPDJSubstantially EquivalentRoche Diagnostics Operations (Rdo)accessdata.fda.gov
December 19, 2016DEN150057Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5PQOUnknownRoche Diagnosticsaccessdata.fda.gov
December 14, 2016K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerOVKSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
October 19, 2016K162593HDL-Cholesterol Gen.4LBSSubstantially EquivalentRoche Diagnostics Operations (Rdo)accessdata.fda.gov
July 28, 2016K160910Elecsys SyphilisLIPSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
July 27, 2016K161817Tina-quant Cystatin C Gen.2NDYSubstantially EquivalentRoche Diagnostics Operations (Rdo)accessdata.fda.gov
July 25, 2016K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemOCCSubstantially EquivalentIquum, Inc.accessdata.fda.gov
June 13, 2016K160729Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5PMTSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
May 25, 2016K160570Creatine KinaseJHSSubstantially EquivalentRoche Diagnostics Operations (Rdo)accessdata.fda.gov
April 27, 2016K152227Elecsys Cortisol II, Cortisol II CalSetJFTSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
April 8, 2016K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIKXTSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
January 8, 2016K152245ONLINE TDM Vancomycin Gen.3LEHSubstantially EquivalentRoche Diagnostics Operations (Rdo)accessdata.fda.gov
October 22, 2015K151578Carbamazepine Gen 4KLTSubstantially EquivalentRoche Diagnostics Operations (Rdo)accessdata.fda.gov
October 2, 2015K152526Elecsys Progesterone III CalSetJITSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
September 24, 2015K151786Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSetCDDSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
August 6, 2015K143534Elecsys CA-125 II assayLTKSubstantially EquivalentRoche Professional Diagnosticsaccessdata.fda.gov
June 1, 2015K150617cobas HSV 1 and 2 TestOQOSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
May 20, 2015K142422cobas Cdiff TestOZNSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
January 28, 2015K143691LDLC3 LDL-Cholesterol Gen.3LBRSubstantially EquivalentRoche Diagnostics Operations (Rdo)accessdata.fda.gov
December 19, 2014K143342Elecsys T-Uptake CalsetJITSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
December 17, 2014K142721cobas MRSA/SA TestNQXSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
December 9, 2014K141925TOTAL PROTEIN URINE/CSF GEN.3JIQSubstantially EquivalentRoche Diagnostics Operations (Rdo)accessdata.fda.gov
November 25, 2014K141928COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATORDKBSubstantially EquivalentRoche Diagnostics Operations (Rdo)accessdata.fda.gov
November 4, 2014K141338LIAT STREP A ASSAYPGXSubstantially EquivalentIquum, Inc.accessdata.fda.gov
October 24, 2014K142133ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGMLFZSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
October 17, 2014K141426ELECSYS FOLATE IIICGNSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
August 12, 2014K142021Elecsys Estradiol III CalSetJITSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
July 17, 2014K141143COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SETNDYSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
June 6, 2014K140112CA 125 II CALSET IIJITSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
May 8, 2014K140404ELECSYS CK-MB STAT IMMUNOASSAYJHYSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
February 28, 2014K131605ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAYLFZSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
January 27, 2014K131244ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSETCECSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
December 4, 2013K132828ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3JKRSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
December 2, 2013K132270COBAS CT/NG V2.0 TESTLSLSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
February 23, 2021P190034Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheckSEI10May 22, 2025accessdata.fda.gov
February 3, 2021P190005Elecsys Anti-HBe, PreciControl Anti-HBeSEI7May 22, 2025accessdata.fda.gov
June 18, 2020P200014cobas® EZH2 Mutation TestOWD10March 17, 2026accessdata.fda.gov
June 1, 2017P160041COBAS CMVPAB46October 10, 2024accessdata.fda.gov
December 23, 2016P160019Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg IILOM19May 22, 2025accessdata.fda.gov
October 14, 2015P150015COBAS HCV TESTMZP42June 2, 2021accessdata.fda.gov
October 14, 2015P150014COBAS HBV TESTMKT57October 17, 2025accessdata.fda.gov
June 11, 2015P140021ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCVMZO16April 24, 2019accessdata.fda.gov
March 14, 2014P130015ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAGLOM22May 22, 2025accessdata.fda.gov
October 26, 2011P110022ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGMSEI32May 22, 2025accessdata.fda.gov
August 17, 2011P110020COBAS 4800 BRAF V600 MUTATION TESTOWD44March 17, 2026accessdata.fda.gov
June 27, 2011P100032ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZERSEI22May 22, 2025accessdata.fda.gov
June 22, 2011P100031ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBCSEI31May 22, 2025accessdata.fda.gov
April 19, 2011P100020COBAS HPV TESTMAQ64March 17, 2026accessdata.fda.gov
April 29, 2010P090008ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZERMZO20April 24, 2019accessdata.fda.gov
September 4, 2008P050028COBAS TAQMAN HBV TESTMKT88October 4, 2024accessdata.fda.gov
February 28, 2002P010054ELECSYS ANTI-HBSSEI45May 22, 2025accessdata.fda.gov
July 3, 2001P000012COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0MZP51August 4, 2016accessdata.fda.gov
June 1, 2001P990012ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAGLOM30April 24, 2019accessdata.fda.gov
December 12, 2000P000027ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECKLTJ42April 29, 2026accessdata.fda.gov
November 22, 2000P990056ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSETMTF43April 29, 2026accessdata.fda.gov
October 2, 1996P920031EMIT 2000 CYCLOSPORINE SPECIFIC ASSAYMKW3July 24, 2002accessdata.fda.gov

Compare with other makers

Updated October 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.