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Data / Medical devices / Germany / Roche Diagnostics GMBH

Roche Diagnostics GMBH: FDA-registered device maker in PENZBERG Bavaria, Germany, 4 510(k) clearances and 1 PMA approval

Roche Diagnostics GMBH is registered with the FDA (registration 9610529) in PENZBERG Bavaria, Germany. It lists 109 device types. The FDA files 4 510(k) clearances and 1 PMA approval under its listings, the newest dated August 17, 2011. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Roche Diagnostics GMBH
FDA registration number
9610529
FEI number
3002806560
Address
Nonnenwald 2, PENZBERG Bavaria, Germany, D-82377
Owner or operator
Roche Diagnostics Operations Inc. (9039767)
Roles
Manufacturer, Specification developer
First device listed
March 6, 2001
Registered through
2027
Brand names listed
A1CD, cobas c 503, AST 1100Tests cobas c 701, ATRX CM Rabbit Polyclonal Antibody, Accelerator I 1 x 100ML, Acid Wash Solution, Acid wash Solution 2x1,8 L, Acid wash Solution 2x2 L, Activator for cobas c,Integra,c111 and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid Phosphatase, Disodium PhenylphosphateCJX2Manufactureraccessdata.fda.gov
Acid, Folic, RadioimmunoassayCGN2Specification developeraccessdata.fda.gov
Acid, Lactic, Enzymatic MethodKHP1Manufactureraccessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)KNK1Manufactureraccessdata.fda.gov
Albumin, Antigen, Antiserum, ControlDCF2Manufactureraccessdata.fda.gov
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme MethodDIC2Manufactureraccessdata.fda.gov
Alkaline Picrate, Colorimetry, CreatinineCGX2Manufactureraccessdata.fda.gov
Alpha-1-Antitrypsin, Antigen, Antiserum, ControlDEM2Manufactureraccessdata.fda.gov
Alpha-1-Lipoprotein, Antigen, Antiserum, ControlDER2Manufactureraccessdata.fda.gov
Amikacin Serum AssayKLP2Manufactureraccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Manufactureraccessdata.fda.gov
Assay, Glycosylated HemoglobinLCP2Manufactureraccessdata.fda.gov
Assay, Porphyrin, Spectrophotometry, LithiumNDW2Manufactureraccessdata.fda.gov
Biuret (Colorimetric), Total ProteinCEK2Manufactureraccessdata.fda.gov
Bromcresol Green Dye-Binding, AlbuminCIX2Manufactureraccessdata.fda.gov
Bromcresol Purple Dye-Binding, AlbuminCJW2Manufactureraccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Manufactureraccessdata.fda.gov
Calibrator, SecondaryJIT2Specification developeraccessdata.fda.gov
Calibrators, Drug MixtureDKB2Manufactureraccessdata.fda.gov
Calibrators, Drug SpecificDLJ2Manufactureraccessdata.fda.gov
Cardiac C-Reactive Protein, Antigen, Antiserum, And ControlNQD2Manufactureraccessdata.fda.gov
Catalytic Methods, AmylaseJFJ2Manufactureraccessdata.fda.gov
Clinical Sample ConcentratorJJH1Manufactureraccessdata.fda.gov
Colorimetry, AcetaminophenLDP2Manufactureraccessdata.fda.gov
Colorimetry, CholinesteraseDIH1Manufactureraccessdata.fda.gov
Colorimetry, SalicylateDKJ2Manufactureraccessdata.fda.gov
Complement C3, Antigen, Antiserum, ControlCZW2Manufactureraccessdata.fda.gov
Complement C4, Antigen, Antiserum, ControlDBI2Manufactureraccessdata.fda.gov
Cresolphthalein Complexone, CalciumCIC2Manufactureraccessdata.fda.gov
Diazo Colorimetry, BilirubinCIG2Manufactureraccessdata.fda.gov
Differential Rate Kinetic Method, Cpk Or IsoenzymesJHS2Manufactureraccessdata.fda.gov
Drug Mixture Control MaterialsDIF1Manufactureraccessdata.fda.gov
Drug Specific Control MaterialsLAS1Manufactureraccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Manufactureraccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Manufactureraccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Manufactureraccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Manufactureraccessdata.fda.gov
Enzymatic Method, AmmoniaJIF1Manufactureraccessdata.fda.gov
Enzymatic, Carbon-DioxideKHS2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, CocaineJXO2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, DigoxinKXT2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, DiphenylhydantoinDIP2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, N-AcetylprocainamideLAN2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total ThyroxineKLI2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUManufactureraccessdata.fda.gov
Enzyme Immunoassay, PhenobarbitalDLZ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, ProcainamideLAR2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, PropoxypheneJXN2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, QuinidineLBZ2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, TheophyllineKLS2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, Valproic AcidLEG2Manufactureraccessdata.fda.gov
Ferritin, Antigen, Antiserum, ControlDBF2Manufactureraccessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding CapacityJMO1Manufactureraccessdata.fda.gov
Fibrin Split ProductsGHH2Manufactureraccessdata.fda.gov
Fluorescence Polarization Immunoassay, CarbamazepineLGI2Manufactureraccessdata.fda.gov
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)MOJ2Manufactureraccessdata.fda.gov
Fluorescence Polarization Immunoassay, PhenobarbitalLGQ2Manufactureraccessdata.fda.gov
Fluorescence Polarization Immunoassay, TheophyllineLGS2Manufactureraccessdata.fda.gov
General Purpose ReagentPPM1Manufactureraccessdata.fda.gov
Haptoglobin, Antigen, Antiserum, ControlDAD2Manufactureraccessdata.fda.gov
Hexokinase, GlucoseCFR2Manufactureraccessdata.fda.gov
Iga, Antigen, Antiserum, ControlCZP2Manufactureraccessdata.fda.gov
Igg, Antigen, Antiserum, ControlDEW2Manufactureraccessdata.fda.gov
Igm (Mu Chain Specific), Antigen, Antiserum, ControlDAO2Manufactureraccessdata.fda.gov
Immunochemical, CeruloplasminCHN2Manufactureraccessdata.fda.gov
Immunohistochemistry Reagents And KitsNJT1Manufactureraccessdata.fda.gov
Kinetic Method, Gamma-Glutamyl TranspeptidaseJQB1Manufactureraccessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, HdlLBS1Manufactureraccessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesCDT1Manufactureraccessdata.fda.gov
Lipoprotein X, Antigen, Antiserum, ControlDEL1Manufactureraccessdata.fda.gov
Lipoprotein, Low-Density, Antigen, Antiserum, ControlDFC2Manufactureraccessdata.fda.gov
Method, Nephelometric, Immunoglobulins (G, A, M)CFN2Manufactureraccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Manufacturer, Specification developeraccessdata.fda.gov
Mycophenolic Acid Test SystemOAV2Manufactureraccessdata.fda.gov
Myoglobin, Antigen, Antiserum, ControlDDR2Manufactureraccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate DehydrogenaseCFJ2Manufactureraccessdata.fda.gov
Nad-Nadh, Specific Reagent For Alcohol Enzyme MethodDML2Manufactureraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/SgptCKA1Manufactureraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/SgotCIT2Manufactureraccessdata.fda.gov
NephelometerJZW1Manufactureraccessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesCJE2Manufactureraccessdata.fda.gov
Olive Oil Emulsion (Turbidimetric), LipaseCET1Manufactureraccessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic PhosphorusCEO1Manufactureraccessdata.fda.gov
Photometric Method, Iron (Non-Heme)JIY1Manufactureraccessdata.fda.gov
Photometric Method, MagnesiumJGJ1Manufactureraccessdata.fda.gov
Radioassay, Triiodothyronine UptakeKHQ2Manufactureraccessdata.fda.gov
Radioimmunoassay, Lsd (125-I)DLB2Manufactureraccessdata.fda.gov
Radioimmunoassay, MethaqualoneKXS2Manufactureraccessdata.fda.gov
Radioimmunoassay, TobramycinKLB2Manufactureraccessdata.fda.gov
Radioimmunoassay, VancomycinLEH2Manufactureraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Specification developeraccessdata.fda.gov
Somatic Gene Mutation Detection SystemOWD3Manufactureraccessdata.fda.gov
System, Test, Beta-2-Microglobulin ImmunologicalJZG2Manufactureraccessdata.fda.gov
System, Test, C-Reactive ProteinDCN2Manufactureraccessdata.fda.gov
System, Test, Low Density, LipoproteinMRR1Manufactureraccessdata.fda.gov
System, Test, Rheumatoid FactorDHR2Manufactureraccessdata.fda.gov
System, Test, Urinary Methylmalonic AcidLPT2Manufactureraccessdata.fda.gov
Test, Cystatin CNDY2Manufactureraccessdata.fda.gov
Transferrin, Antigen, Antiserum, ControlDDG2Manufactureraccessdata.fda.gov
Turbidimetric Method, LipoproteinsJHN1Manufactureraccessdata.fda.gov
Turbidimetric, Total ProteinJGQ2Manufactureraccessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea NitrogenCDQ2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 9, 2010K100853COBAS 8000 MODULAR SERIES ANALYZERDCFSubstantially EquivalentRoche Diagnostics Corp.accessdata.fda.gov
June 19, 2009K082340ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYSCGNSubstantially EquivalentRoche Diagnostics Corp.accessdata.fda.gov
June 14, 1996K961481ELECSYS 2010 ANALYZERJJESubstantially EquivalentBoehringer Mannheim Corp.accessdata.fda.gov
September 8, 1995K951595ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTESCGXSubstantially EquivalentRoche Diagnostic Systems, Inc.accessdata.fda.gov

PMA approvals

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

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
August 17, 2011P110020COBAS 4800 BRAF V600 MUTATION TESTOWD44March 17, 2026accessdata.fda.gov

Compare with other makers

Updated March 17, 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.