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Data / Medical devices / Hungary / Diamond Diagnostics Inc.

Diamond Diagnostics Inc.: FDA-registered device maker in Budapest, Hungary, 124 510(k) clearances

Diamond Diagnostics Inc. is registered with the FDA (registration 3006198300) in Budapest, Hungary. It lists 241 device types. The FDA files 124 510(k) clearances under its listings, the newest dated August 4, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3006198300
Address
6 Oradna Street, Budapest, Hungary, 1044
Owner or operator
Diamond Diagnostics Inc. (10028706)
Roles
Contract manufacturer, Exporter to the US
First device listed
February 26, 2009
Registered through
2026
Brand names listed
ANALYZER, CHEMISTRY, Analyzer, Assay System, Automated Test System, BK BUN, BK Creatinine, BK Glucose, BK ISE and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid HematinGGF2Exporter to the USaccessdata.fda.gov
Acid Phosphatase (Prostatic), Tartrate InhibitedJFH2Exporter to the USaccessdata.fda.gov
Acid Phosphatase, Disodium PhenylphosphateCJX2Exporter to the USaccessdata.fda.gov
Acid Phosphatase, Naphthyl PhosphateCKB2Exporter to the USaccessdata.fda.gov
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)JMA1Exporter to the USaccessdata.fda.gov
Acid, Folic, RadioimmunoassayCGN2Exporter to the USaccessdata.fda.gov
Acid, Lactic, Enzymatic MethodKHP1Exporter to the USaccessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)KNK1Exporter to the USaccessdata.fda.gov
Acid, Uric, Uricase (U.V.)CDO1Exporter to the USaccessdata.fda.gov
Activated Whole Blood Clotting TimeJBP2Exporter to the USaccessdata.fda.gov
Albumin, Antigen, Antiserum, ControlDCF2Exporter to the USaccessdata.fda.gov
Albumin, Rhodamine, Antigen, Antiserum, ControlDFJ2Exporter to the USaccessdata.fda.gov
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme MethodDIC2Exporter to the USaccessdata.fda.gov
Alkaline Picrate, Colorimetry, CreatinineCGX2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Alpha-1-Antitrypsin, Antigen, Antiserum, ControlDEM2Exporter to the USaccessdata.fda.gov
Alpha-1-Lipoprotein, Antigen, Antiserum, ControlDER2Exporter to the USaccessdata.fda.gov
Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, ControlDEF1Exporter to the USaccessdata.fda.gov
Amikacin Serum AssayKLP2Exporter to the USaccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Analyzer, Chemistry, Centrifugal, For Clinical UseJJG1Exporter to the USaccessdata.fda.gov
Analyzer, Chemistry, Micro, For Clinical UseJJF1Exporter to the USaccessdata.fda.gov
Assay, CarboxyhemoglobinGHS2Exporter to the USaccessdata.fda.gov
Assay, Fetal HemoglobinKQI2Exporter to the USaccessdata.fda.gov
Assay, Glycosylated HemoglobinLCP2Exporter to the USaccessdata.fda.gov
Assay, Porphyrin, Spectrophotometry, LithiumNDW2Exporter to the USaccessdata.fda.gov
Atp And Creatine Kinase (Enzymatic), CreatineJLB1Exporter to the USaccessdata.fda.gov
Automated Urinalysis SystemKQO1Exporter to the USaccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Exporter to the USaccessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test SystemMQM1Exporter to the USaccessdata.fda.gov
Biosensor, Immunoassay, Cpk Or IsoenzymesMYT2Exporter to the USaccessdata.fda.gov
Biuret (Colorimetric), Total ProteinCEK2Exporter to the USaccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Exporter to the USaccessdata.fda.gov
Bordetella Pertussis Dna Assay SystemOZZ2Contract manufactureraccessdata.fda.gov
Breast Milk, Rhodamine, Antigen, Antiserum, ControlDGI1Exporter to the USaccessdata.fda.gov
Bromcresol Green Dye-Binding, AlbuminCIX2Exporter to the USaccessdata.fda.gov
Bromcresol Purple Dye-Binding, AlbuminCJW2Exporter to the USaccessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And ControlDCK2Exporter to the USaccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Calibrator, PrimaryJIS2Exporter to the USaccessdata.fda.gov
Calibrator, SecondaryJIT2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Calibrators, Drug MixtureDKB2Exporter to the USaccessdata.fda.gov
Calibrators, Drug SpecificDLJ2Exporter to the USaccessdata.fda.gov
Cardiac C-Reactive Protein, Antigen, Antiserum, And ControlNQD2Exporter to the USaccessdata.fda.gov
Catalytic Methods, AmylaseJFJ2Exporter to the USaccessdata.fda.gov
Clinical Sample ConcentratorJJH1Exporter to the USaccessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical UseJJQ1Exporter to the USaccessdata.fda.gov
Colorimetric Method, Cpk Or IsoenzymesJHY2Exporter to the USaccessdata.fda.gov
Colorimetry, AcetaminophenLDP2Exporter to the USaccessdata.fda.gov
Colorimetry, CholinesteraseDIH1Exporter to the USaccessdata.fda.gov
Colorimetry, SalicylateDKJ2Exporter to the USaccessdata.fda.gov
Column Chromatography & Color Development, HydroxyprolineJMM1Exporter to the USaccessdata.fda.gov
Complement C3, Antigen, Antiserum, ControlCZW2Exporter to the USaccessdata.fda.gov
Complement C4, Antigen, Antiserum, ControlDBI2Exporter to the USaccessdata.fda.gov
Control, HematocritGLK2Exporter to the USaccessdata.fda.gov
Controls For Blood-Gases, (Assayed And Unassayed)JJS1Contract manufactureraccessdata.fda.gov
Counter, Cell, Automated (Particle Counter)GKL2Exporter to the USaccessdata.fda.gov
Counter, Differential CellGKZ2Exporter to the USaccessdata.fda.gov
Counter, Urine ParticleLKM2Exporter to the USaccessdata.fda.gov
Cresolphthalein Complexone, CalciumCIC2Exporter to the USaccessdata.fda.gov
Culture Media, Non-Propagating TransportJSM1Exporter to the USaccessdata.fda.gov
Device, Hematocrit MeasuringJPI2Exporter to the USaccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Exporter to the USaccessdata.fda.gov
Diazo Colorimetry, BilirubinCIG2Exporter to the USaccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Exporter to the USaccessdata.fda.gov
Differential Rate Kinetic Method, Cpk Or IsoenzymesJHS2Exporter to the USaccessdata.fda.gov
Dna Probe, Nucleic Acid Amplification, ChlamydiaMKZ1Exporter to the USaccessdata.fda.gov
Dna-Reagents, NeisseriaLSL2Exporter to the USaccessdata.fda.gov
Drug Mixture Control MaterialsDIF1Exporter to the USaccessdata.fda.gov
Drug Specific Control MaterialsLAS1Exporter to the USaccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Exporter to the USaccessdata.fda.gov
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhCHL2Exporter to the USaccessdata.fda.gov
Electrode, Ion Based, Enzymatic, CreatinineCGL2Exporter to the USaccessdata.fda.gov
Electrode, Ion Specific, CalciumJFP2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Electrode, Ion Specific, Urea NitrogenCDS2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Exporter to the USaccessdata.fda.gov
Enzymatic Method, AmmoniaJIF1Exporter to the USaccessdata.fda.gov
Enzymatic Method, CreatinineJFY2Exporter to the USaccessdata.fda.gov
Enzymatic, Carbon-DioxideKHS2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, CarbamazepineKLT2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, CocaineJXO2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, DigitoxinLFM2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, DigoxinKXT2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, DiphenylhydantoinDIP2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, GentamicinLCD2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, N-AcetylprocainamideLAN2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total ThyroxineKLI2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUExporter to the USaccessdata.fda.gov
Enzyme Immunoassay, PhenobarbitalDLZ2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, ProcainamideLAR2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, PropoxypheneJXN2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, QuinidineLBZ2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, TheophyllineKLS2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, Valproic AcidLEG2Exporter to the USaccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, CytomegalovirusLFZ2Exporter to the USaccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-SpecificLGC2Exporter to the USaccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, RubellaLFX2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiLGD2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Ferritin, Antigen, Antiserum, ControlDBF2Exporter to the USaccessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding CapacityJMO1Exporter to the USaccessdata.fda.gov
Fibrin Split ProductsGHH2Exporter to the USaccessdata.fda.gov
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlDAP2Contract manufactureraccessdata.fda.gov
Flame Emission Photometer For Clinical UseJJO1Exporter to the USaccessdata.fda.gov
Flame Photometry, LithiumJIH2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Fluorescence Polarization Immunoassay, CarbamazepineLGI2Exporter to the USaccessdata.fda.gov
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)MOJ2Exporter to the USaccessdata.fda.gov
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)LGR2Exporter to the USaccessdata.fda.gov
Fluorescence Polarization Immunoassay, PhenobarbitalLGQ2Exporter to the USaccessdata.fda.gov
Fluorescence Polarization Immunoassay, TheophyllineLGS2Exporter to the USaccessdata.fda.gov
Fluorescent Immunoassay, TobramycinLCR2Exporter to the USaccessdata.fda.gov
Fluorometer, For Clinical UseKHO1Exporter to the USaccessdata.fda.gov
Fluorometric Method, Cpk Or IsoenzymesJHX2Exporter to the USaccessdata.fda.gov
Fluorometric, CalciumJFO2Exporter to the USaccessdata.fda.gov
Gas Chromatography, AmphetamineDOD2Exporter to the USaccessdata.fda.gov
Gas Chromatography, MethamphetamineLAF2Exporter to the USaccessdata.fda.gov
Glucose Oxidase, GlucoseCGA2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Haptoglobin, Antigen, Antiserum, ControlDAD2Exporter to the USaccessdata.fda.gov
Helicobacter PyloriLYR1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Hemoglobin A2 QuantitationJPD2Exporter to the USaccessdata.fda.gov
Hepatitis A Test (Antibody And Igm Antibody)LOL2Exporter to the USaccessdata.fda.gov
Hexokinase, GlucoseCFR2Exporter to the USaccessdata.fda.gov
Human Metapneumovirus (Hmpv) Rna Assay SystemOEM2Contract manufactureraccessdata.fda.gov
Iga, Antigen, Antiserum, ControlCZP2Exporter to the USaccessdata.fda.gov
Ige, Antigen, Antiserum, ControlDGC2Exporter to the USaccessdata.fda.gov
Ige, Peroxidase, Antigen, Antiserum, ControlDGO2Exporter to the USaccessdata.fda.gov
Igg, Antigen, Antiserum, ControlDEW2Exporter to the USaccessdata.fda.gov
Igm (Mu Chain Specific), Antigen, Antiserum, ControlDAO2Exporter to the USaccessdata.fda.gov
Immunoassay Method, Troponin SubunitMMI2Exporter to the USaccessdata.fda.gov
Immunochemical, CeruloplasminCHN2Exporter to the USaccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Exporter to the USaccessdata.fda.gov
Influenza A Virus Subtype Differentiation Nucleic Acid AssayOEP2Contract manufactureraccessdata.fda.gov
Instrument, Coagulation, AutomatedGKP2Exporter to the USaccessdata.fda.gov
Instrument, Hematocrit, AutomatedGKF2Exporter to the USaccessdata.fda.gov
Instrumentation For Clinical Multiplex Test SystemsNSU2Exporter to the USaccessdata.fda.gov
Kinetic Method, Gamma-Glutamyl TranspeptidaseJQB1Exporter to the USaccessdata.fda.gov
Kit, Test,Alpha-Fetoprotein For Testicular CancerLOJ2Exporter to the USaccessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, HdlLBS1Exporter to the USaccessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesCDT1Exporter to the USaccessdata.fda.gov
Lipoprotein X, Antigen, Antiserum, ControlDEL1Exporter to the USaccessdata.fda.gov
Lipoprotein, Low-Density, Antigen, Antiserum, ControlDFC2Exporter to the USaccessdata.fda.gov
Mercuric Thiocyanate, Colorimetry, ChlorideCHJ2Exporter to the USaccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Exporter to the USaccessdata.fda.gov
Method, Nephelometric, Immunoglobulins (G, A, M)CFN2Exporter to the USaccessdata.fda.gov
Monocyte Distribution Width Quantitative Measurement For Sepsis Risk AssessmentQFS2Exporter to the USaccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Mycophenolic Acid Test SystemOAV2Exporter to the USaccessdata.fda.gov
Mycoplasma Pneumoniae Dna Assay SystemOZX2Contract manufactureraccessdata.fda.gov
Myoglobin, Antigen, Antiserum, ControlDDR2Exporter to the USaccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Cpk Or IsoenzymesCGS2Exporter to the USaccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate DehydrogenaseCFJ2Exporter to the USaccessdata.fda.gov
Nad-Nadh, Specific Reagent For Alcohol Enzyme MethodDML2Exporter to the USaccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/SgptCKA1Exporter to the USaccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/SgotCIT2Exporter to the USaccessdata.fda.gov
NephelometerJZW1Exporter to the USaccessdata.fda.gov
Nephelometer, For Clinical UseJQX1Exporter to the USaccessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesCJE2Exporter to the USaccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Exporter to the USaccessdata.fda.gov
Non-Sars Coronavirus Multiplex Nucleic Acid AssayOTG2Contract manufactureraccessdata.fda.gov
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen TestNJR1Exporter to the USaccessdata.fda.gov
Olive Oil Emulsion (Turbidimetric), LipaseCET1Exporter to the USaccessdata.fda.gov
Oximeter To Measure HemoglobinGLY2Exporter to the USaccessdata.fda.gov
OxyhemoglobinGGZ2Exporter to the USaccessdata.fda.gov
Parainfluenza Multiplex Nucleic Acid AssayOOU2Contract manufactureraccessdata.fda.gov
Ph Rate Measurement, Carbon-DioxideJFL2Exporter to the USaccessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic PhosphorusCEO1Exporter to the USaccessdata.fda.gov
Photometric Method, Iron (Non-Heme)JIY1Exporter to the USaccessdata.fda.gov
Photometric Method, MagnesiumJGJ1Exporter to the USaccessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate CancersLTJ2Exporter to the USaccessdata.fda.gov
Radioassay, Triiodothyronine UptakeKHQ2Exporter to the USaccessdata.fda.gov
Radioassay, Vitamin B12CDD2Exporter to the USaccessdata.fda.gov
Radioimmunoassay (Two-Site Solid Phase), FerritinJMG2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, ActhCKG2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, C-Peptides Of ProinsulinJKD1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, CortisolCGR2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Cyclic GmpCGT2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)JKC1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, EstradiolCHP1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, EstriolCGI1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating HormoneCGJ1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Free ThyroxineCEC2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Human Growth HormoneCFL1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Human Placental LactogenJMF2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Immunoglobulins (D, E)JHR2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Immunoglobulins (G, A, M)CFQ2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Immunoreactive InsulinCFP1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Lsd (125-I)DLB2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Luteinizing HormoneCEP1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, MethaqualoneKXS2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Parathyroid HormoneCEW2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, ProgesteroneJLS1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)CFT1Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Testosterones And DihydrotestosteroneCDZ1Contract manufacturer, Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Thyroxine-Binding GlobulinCEE2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, TobramycinKLB2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Total TriiodothyronineCDP2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, VancomycinLEH2Exporter to the USaccessdata.fda.gov
Reagent, Borrelia Serological ReagentLSR2Contract manufactureraccessdata.fda.gov
Real Time Nucleic Acid Amplification SystemOOI2Exporter to the USaccessdata.fda.gov
Refractometer For Clinical UseJRE1Exporter to the USaccessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay SystemOCC2Contract manufacturer, Exporter to the USaccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Exporter to the USaccessdata.fda.gov
Slide Stainer, AutomatedKPA1Exporter to the USaccessdata.fda.gov
System, Hemoglobin, AutomatedGKR2Exporter to the USaccessdata.fda.gov
System, Multipurpose For In Vitro Coagulation StudiesJPA2Exporter to the USaccessdata.fda.gov
System, Test, Automated Blood Grouping And AntibodyKSZ2Exporter to the USaccessdata.fda.gov
System, Test, Automated, Antimicrobial Susceptibility, Short IncubationLON2Contract manufactureraccessdata.fda.gov
System, Test, Beta-2-Microglobulin ImmunologicalJZG2Exporter to the USaccessdata.fda.gov
System, Test, C-Reactive ProteinDCN2Exporter to the USaccessdata.fda.gov
System, Test, Carcinoembryonic AntigenDHX2Exporter to the USaccessdata.fda.gov
System, Test, Human Chorionic GonadotropinDHA2Exporter to the USaccessdata.fda.gov
System, Test, Immunological, Antigen, TumorMOI2Exporter to the USaccessdata.fda.gov
System, Test, Low Density, LipoproteinMRR1Exporter to the USaccessdata.fda.gov
System, Test, Radioallergosorbent (Rast) ImmunologicalDHB2Exporter to the USaccessdata.fda.gov
System, Test, Rheumatoid FactorDHR2Exporter to the USaccessdata.fda.gov
System, Test, ThyroglobulinMSW2Exporter to the USaccessdata.fda.gov
System, Test, Thyroid AutoantibodyJZO2Exporter to the USaccessdata.fda.gov
System, Test, Urinary Methylmalonic AcidLPT2Exporter to the USaccessdata.fda.gov
Test, Cystatin CNDY2Exporter to the USaccessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)LTK2Exporter to the USaccessdata.fda.gov
Test, Equipment, Automated Bloodborne PathogenMZANExporter to the USaccessdata.fda.gov
Test, Natriuretic PeptideNBC2Exporter to the USaccessdata.fda.gov
Test, Time, ProthrombinGJS2Exporter to the USaccessdata.fda.gov
Test, Urine LeukocyteLJX1Exporter to the USaccessdata.fda.gov
Transferrin, Antigen, Antiserum, ControlDDG2Exporter to the USaccessdata.fda.gov
Trichomonas Vaginalis Nucleic Acid Amplification Test SystemOUY2Exporter to the USaccessdata.fda.gov
Turbidimetric Method, LipoproteinsJHN1Exporter to the USaccessdata.fda.gov
Turbidimetric, Total ProteinJGQ2Exporter to the USaccessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea NitrogenCDQ2Exporter to the USaccessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test SystemLPS2Exporter to the USaccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Contract manufacturer, Exporter to the USaccessdata.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 124.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 4, 2023K220031Alinity h-series SystemGKZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
July 13, 2023K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)JLWSubstantially EquivalentSiemens Healthcare Diagnostics, Inc.accessdata.fda.gov
June 7, 2023K212183STA R Max 3, STA Compact Max 3JPASubstantially EquivalentDiagnostica Stago S.A.Saccessdata.fda.gov
May 19, 2023K230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesDHASubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
November 10, 2022K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerJLWSubstantially EquivalentBeckman Coulter, Inc.accessdata.fda.gov
September 16, 2022K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHCFRSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
August 20, 2021K203790GEM Premier 5000CHLSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
April 16, 2020K193124Unicel DxH 800 Coulter Cellular Analysis SystemGKZSubstantially EquivalentBeckman Coulteraccessdata.fda.gov
March 15, 2019K190294CELL-DYN Emerald 22 AL SystemGKZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
October 30, 2018K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemJFYSubstantially EquivalentOrtho-Clinical Diagnostics, Inc.accessdata.fda.gov
August 15, 2018K181289Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 SystemOCCSubstantially EquivalentCepheidaccessdata.fda.gov
April 23, 2018K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKMSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
October 23, 2017K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemDHASubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
August 22, 2017K163342i-STAT Hematocrit test with i-STAT Alinity SystemJPISubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
December 16, 2016K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerJGSSubstantially EquivalentBeckman Coulter, Inc.accessdata.fda.gov
March 3, 2016K160276ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)GKPSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
January 26, 2016K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iJPASubstantially EquivalentSiemens Healthcare Diagnostics Products GmbHaccessdata.fda.gov
January 11, 2016K150678Sysmex Automated Blood Coagulation Analyzer CS-5100JPASubstantially EquivalentSiemens Healthcare Diagnostic Products GmbHaccessdata.fda.gov
December 13, 2015K150877ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LASGKPSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
November 20, 2015K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) SystemJLWSubstantially EquivalentSiemens Healthcare Diagnostics, Inc.accessdata.fda.gov
October 16, 2015K151565Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection KitOUYSubstantially EquivalentCepheidaccessdata.fda.gov
September 18, 2015K143720Dimension Vista MMB AssayJHYSubstantially EquivalentSiemens Healthcare Diagnosticsaccessdata.fda.gov
December 5, 2014K141681SYSMEX XN SERIESGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
May 5, 2014K140887COBAS CT/NG V2.0 TESTLSLSubstantially EquivalentRoche Molecular Systems, Inc.accessdata.fda.gov
August 22, 2013K131126OPTI CCA-TS2CHLSubstantially EquivalentOpti Medical Systems, Inc.accessdata.fda.gov
April 23, 2013K123018ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULECFRSubstantially EquivalentAlfa Wassermann Diagnostic Technologies, Inc.accessdata.fda.gov
March 22, 2013K130276DIMENSION EXL WITH LM SYSTEMJJESubstantially EquivalentSiemens Healthcare Diagnostics, Inc.accessdata.fda.gov
March 8, 2013K123955QUANTSTUDIO DX REAL-TIME PCR INSTRUMENTOOISubstantially EquivalentLife Technologies Corporationaccessdata.fda.gov
February 12, 2013K130090STA COMPACT MAXJPASubstantially EquivalentDiagnostica Stago, Incorporatedaccessdata.fda.gov
October 19, 2012K112605SYSMEX XN-SERIESGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
August 2, 2012K111534ABACUS 3CPGKZSubstantially EquivalentDiatron U.S., Inc.accessdata.fda.gov
March 27, 2012K112755ABACUS 5GKZSubstantially EquivalentDiatron U.S., Inc.accessdata.fda.gov
March 23, 2012K110520BIOLIS 12ICEMSubstantially EquivalentTokyo Boeki Medisys, Inc.accessdata.fda.gov
December 23, 2011K112412AU5800(R) CHEMISTRY ANALYZERCEMSubstantially EquivalentBeckman Coulter, Inc.accessdata.fda.gov
December 22, 2011K110381CELL-DYN EMERALD 22 SYSTEMGKZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
December 1, 2011K103531PRESTIGE 24I; BIOLIS 24I; MGC 240CFRSubstantially EquivalentTokyo Boeki Medisys, Inc.accessdata.fda.gov
June 28, 2011K110035INDIKOJJESubstantially EquivalentThermofisher Scientific OYaccessdata.fda.gov
March 24, 2011K102647ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...JGSSubstantially EquivalentElitechgroup Vital Scientific BVaccessdata.fda.gov
March 23, 2011K101852CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KITKQOSubstantially EquivalentIris International Inc., A Division of Iris Iris Iaccessdata.fda.gov
February 8, 2011K103195I-STAT 1 WIRELESS ANALYZERCGASubstantially EquivalentAbbott Point of Care, Inc.accessdata.fda.gov
January 25, 2011K101741DIATRON PICTUS 400CGASubstantially EquivalentDiatron Groupaccessdata.fda.gov
January 21, 2011K103529LIAISON XL ANALYZER MODEL 10050LOLSubstantially EquivalentDiaSorin, Inc.accessdata.fda.gov
September 9, 2010K100853COBAS 8000 MODULAR SERIES ANALYZERDCFSubstantially EquivalentRoche Diagnostics Corp.accessdata.fda.gov
August 6, 2010K092686ABL90 FLEX SERIESCEMSubstantially EquivalentRadiometer Medical Apsaccessdata.fda.gov
July 6, 2010K093383NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAGOOISubstantially EquivalentbioMerieux, Inc.accessdata.fda.gov
May 28, 2010K092705ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501OOISubstantially EquivalentAbbott Molecular, Inc.accessdata.fda.gov
April 2, 2010K093555COBAS U411 TEST SYSTEMKQOSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
March 30, 2010K091313SYSMEX MODEL XT-4000IGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
February 5, 2010K093861IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLELKMSubstantially EquivalentIris International, Inc.accessdata.fda.gov
December 22, 2009K093167STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZERJPASubstantially EquivalentDiagnostica Stago, Inc.accessdata.fda.gov
October 20, 2009K090703POLY-CHEM 90 GLUCOSECFRSubstantially EquivalentPolymedco, Inc.accessdata.fda.gov
March 9, 2009K083339DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)CICSubstantially EquivalentSiemens Healthcare Diagnostics, Inc.accessdata.fda.gov
February 4, 2009K081495CELL-DYN EMERALD SYSTEMGKZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
December 22, 2008K083173VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEMJLWSubstantially EquivalentOrtho-Clinical Diagnosticsaccessdata.fda.gov
December 12, 2008K082248STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZERJPASubstantially EquivalentDiagnostica Stago, Inc.accessdata.fda.gov
October 10, 2008K082675STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZERJPASubstantially EquivalentDiagnostica Stago, Inc.accessdata.fda.gov
September 30, 2008K082562APPLIED BIOSYSTEMS 7500 FAST DXNSUSubstantially EquivalentApplied Biosystems, Inc.accessdata.fda.gov
September 16, 2008K071132G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8LCPSubstantially EquivalentTosoh Bioscience, Inc.accessdata.fda.gov
July 31, 2008K080370ABL 80 CO-OX SYSTEMCHLSubstantially EquivalentSendx Medical, Inc.accessdata.fda.gov
February 1, 2008K072018BS-200 CHEMISTRY ANALYZER, MODE BS-200CFRSubstantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.accessdata.fda.gov
July 30, 2007K071211COBAS C 111 ANALYZERCITSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
May 25, 2007K070910SYSMEX MODEL UF1000ILKMSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
September 29, 2006K061138ABX PENTRA 400 : CRPDCKSubstantially EquivalentHoriba Abxaccessdata.fda.gov
September 15, 2006K061974GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRITCHLSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
July 25, 2006K060540XPERT, GENEXPERT DX SYSTEMNJRSubstantially EquivalentCepheidaccessdata.fda.gov
July 10, 2006K061667CELL-DYN RUBY SYSTEMGKZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
May 10, 2006K060656SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIESGKZSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
March 31, 2006K052914RX IMOLACEMSubstantially EquivalentRandox Laboratories, Ltd.accessdata.fda.gov
March 13, 2006K060373COBAS 6000 SERIES SYSTEMCEMSubstantially EquivalentRoche Diagnosticsaccessdata.fda.gov
February 21, 2006K060162ACL ELITE; ACL ELITE PROJPASubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
December 16, 2005K052007ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)CFRSubstantially EquivalentHoriba Abxaccessdata.fda.gov
December 7, 2005K051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMGKLSubstantially EquivalentBayer Healthcare, LLCaccessdata.fda.gov
July 21, 2005K051215CELL-DYN SAPPHIRE SYSTEMGKZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
March 14, 2005K042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERJJESubstantially EquivalentStanbio Laboratoryaccessdata.fda.gov
February 15, 2005K040958PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240JJESubstantially EquivalentTokyo Boeki Medical System , Ltd.accessdata.fda.gov
October 8, 2004K041874ABL800 FLEXCHLSubstantially EquivalentRadiometer Medical Apsaccessdata.fda.gov
July 2, 2004K041133MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZERCDDSubstantially EquivalentBayer Healthcare, LLCaccessdata.fda.gov
February 11, 2004K032677SYSMEX POCH-100IGKLSubstantially EquivalentSysmex America, Inc.accessdata.fda.gov
December 17, 2003K033734LIGHTCYCLER INSTRUMENT VERSION 1.2JJFSubstantially EquivalentRoche Diagnostics Corp.accessdata.fda.gov
December 4, 2003K024014RANDOX RX DAYTONACGASubstantially EquivalentRandox Laboratories, Ltd.accessdata.fda.gov
October 17, 2003K032311ROCHE DIAGNOSTICS OMNI S ANALYZERCEMSubstantially EquivalentRoche Diagnostics Corp.accessdata.fda.gov
September 8, 2003K032524ADVIA 60 HEMATOLOGY ANALYZERGKZSubstantially EquivalentBayer Healthcare, LLCaccessdata.fda.gov
July 24, 2003K032013COULTER ACT 5DIFF AL HEMATOLOGY ANALYZERGKZSubstantially EquivalentBeckman Coulter, Inc.accessdata.fda.gov
January 3, 2003K024002PENTRA 80GKZSubstantially EquivalentAbx Diagnosticsaccessdata.fda.gov
August 21, 2002K022603IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZERCEWSubstantially EquivalentDiagnostic Products Corp.accessdata.fda.gov
July 17, 2002K020616BAYER RAPIDPOINT 405 SYSTEMGKRSubstantially EquivalentBayer Diagnostics Corp.accessdata.fda.gov
May 14, 2002K020489G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODEJPDSubstantially EquivalentTosoh Medics, Inc.accessdata.fda.gov
February 5, 2001K003796ADVIA 120 HEMATOLOGYGKZSubstantially EquivalentBayer Corp.accessdata.fda.gov
October 26, 2000K002646ABX MICROS CRPGKZSubstantially EquivalentAbx Diagnosticsaccessdata.fda.gov
December 7, 1999K993299SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500GKPSubstantially EquivalentDade Behring, Inc.accessdata.fda.gov
November 24, 1999K992834GEM PREMIER 3000CHLSubstantially EquivalentInstrumentation Laboratory COaccessdata.fda.gov
May 21, 1999K990346BAYER ADVIA 1650 CHEMISTRY SYSTEMJGSSubstantially EquivalentBayer Corp.accessdata.fda.gov
August 14, 1998K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERGKLSubstantially EquivalentSysmex Corp.accessdata.fda.gov
June 9, 1998K981743OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZERCKBSubstantially EquivalentOlympus America, Inc.accessdata.fda.gov
February 24, 1998K974784AVL OPTI CRITICAL CARE ANALYZERCEMSubstantially EquivalentAvl Scientific Corp.accessdata.fda.gov
February 12, 1998K974651ABBOTT AXSYM SYSTEMJJESubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
June 27, 1997K971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMKHOSubstantially EquivalentTosoh Medics, Inc.accessdata.fda.gov
April 8, 1997K970227IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZERJJESubstantially EquivalentDpc Cirrusaccessdata.fda.gov
October 18, 1996K962919VITROS IMMUNODIAGNOSTIC SYSTEMKHOSubstantially EquivalentJohnson & Johnson Clinical Diagnostics, Inc.accessdata.fda.gov
August 21, 1996K962294IMMAGE IMMUNOCHEMISTRY SYSTEMJQXSubstantially EquivalentBeckman Instruments, Inc.accessdata.fda.gov

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Updated August 4, 2023. 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.