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Data / Medical devices / United States / Abbott Laboratories

Abbott Laboratories: FDA-registered device maker in Lake Forest, IL, United States, 218 510(k) clearances and 9 PMA approvals

Abbott Laboratories is registered with the FDA (registration 3005333358) in Lake Forest, IL, United States. It lists 192 device types. The FDA files 218 510(k) clearances and 9 PMA approvals under its listings, the newest dated September 23, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Abbott Laboratories
FDA registration number
3005333358
Address
Conway Park 675 North Field Drive, Lake Forest, IL, United States, 60045
Owner or operator
ABBOTT LABORATORIES (1415939)
Roles
Complaint file establishment
First device listed
December 13, 1977
Registered through
2027
Brand names listed
20X SSC, 500g, ACE Calibrator (LN 06U8201), ACE Calibrator (LN 06U8601), ACE Control (LN 06U8210), ACE Control (LN 06U8610), ACID PHOSPHATASE (ACP) (LN 9D87-21), ACTIVATED ALANINE AMINOTRANSFERASE (A-ALT) (LN 8L92-21, 8L92-41, 8L92-22, 8L92-42), ACTIVATED ASPARTATE AMINOTRANSFERASE (LN 8L91-21, 8L91-41) and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid Phosphatase, Naphthyl PhosphateCKB2Complaint file establishmentaccessdata.fda.gov
Acid, Folic, RadioimmunoassayCGN2Complaint file establishmentaccessdata.fda.gov
Acid, Lactic, Enzymatic MethodKHP1Complaint file establishmentaccessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)KNK1Complaint file establishmentaccessdata.fda.gov
Acid, Uric, Uricase (U.V.)CDO1Complaint file establishmentaccessdata.fda.gov
Alcohol Control MaterialsDKC1Complaint file establishmentaccessdata.fda.gov
Alkaline Picrate, Colorimetry, CreatinineCGX2Complaint file establishmentaccessdata.fda.gov
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, ControlLKL1Complaint file establishmentaccessdata.fda.gov
Alpha-1-Antitrypsin, Antigen, Antiserum, ControlDEM2Complaint file establishmentaccessdata.fda.gov
Alpha-1-Lipoprotein, Antigen, Antiserum, ControlDER2Complaint file establishmentaccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Complaint file establishmentaccessdata.fda.gov
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)NHX2Complaint file establishmentaccessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O ReagentGTQ1Complaint file establishmentaccessdata.fda.gov
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu AdmissionPTF2Complaint file establishmentaccessdata.fda.gov
Assay, Enzyme Linked Immunosorbent, Hepatitis C VirusMZO2Complaint file establishmentaccessdata.fda.gov
Assay, Glycosylated HemoglobinLCP2Complaint file establishmentaccessdata.fda.gov
Assay, Porphyrin, Spectrophotometry, LithiumNDW2Complaint file establishmentaccessdata.fda.gov
Assayed Quality Control Material For Clinical Microbiology AssaysQCH2Complaint file establishmentaccessdata.fda.gov
Azo Dye, CalciumCJY2Complaint file establishmentaccessdata.fda.gov
Bathophenanthroline, Iron Binding CapacityJQF1Complaint file establishmentaccessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test SystemMQM1Complaint file establishmentaccessdata.fda.gov
Biuret (Colorimetric), Total ProteinCEK2Complaint file establishmentaccessdata.fda.gov
Brain Trauma Assessment TestQAT2Complaint file establishmentaccessdata.fda.gov
Bromcresol Green Dye-Binding, AlbuminCIX2Complaint file establishmentaccessdata.fda.gov
Bromcresol Purple Dye-Binding, AlbuminCJW2Complaint file establishmentaccessdata.fda.gov
Bur, Ear, Nose And ThroatEQJ1Complaint file establishmentaccessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And ControlDCK2Complaint file establishmentaccessdata.fda.gov
Calculator/Data Processing Module, For Clinical UseJQP1Complaint file establishmentaccessdata.fda.gov
Calibrator For Cell IndicesKRX2Complaint file establishmentaccessdata.fda.gov
Calibrator For Hemoglobin And Hematocrit MeasurementKRZ2Complaint file establishmentaccessdata.fda.gov
Calibrator For Platelet CountingKRY2Complaint file establishmentaccessdata.fda.gov
Calibrator For Red-Cell And White-Cell CountingKSA2Complaint file establishmentaccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Complaint file establishmentaccessdata.fda.gov
Calibrator, PrimaryJIS2Complaint file establishmentaccessdata.fda.gov
Calibrator, SecondaryJIT2Complaint file establishmentaccessdata.fda.gov
Calibrators, Drug MixtureDKB2Complaint file establishmentaccessdata.fda.gov
Calibrators, Drug SpecificDLJ2Complaint file establishmentaccessdata.fda.gov
Calibrators, Ethyl AlcoholDNN2Complaint file establishmentaccessdata.fda.gov
Cardiac C-Reactive Protein, Antigen, Antiserum, And ControlNQD2Complaint file establishmentaccessdata.fda.gov
Catalytic Methods, AmylaseJFJ2Complaint file establishmentaccessdata.fda.gov
Colorimetric Method, Gamma-Glutamyl TranspeptidaseJPZ1Complaint file establishmentaccessdata.fda.gov
Colorimetry, AcetaminophenLDP2Complaint file establishmentaccessdata.fda.gov
Colorimetry, SalicylateDKJ2Complaint file establishmentaccessdata.fda.gov
Complement C3, Antigen, Antiserum, ControlCZW2Complaint file establishmentaccessdata.fda.gov
Complement C4, Antigen, Antiserum, ControlDBI2Complaint file establishmentaccessdata.fda.gov
Control, Cell Counter, Normal And AbnormalJCN2Complaint file establishmentaccessdata.fda.gov
Control, HemoglobinGGM2Complaint file establishmentaccessdata.fda.gov
Controls For Blood-Gases, (Assayed And Unassayed)JJS1Complaint file establishmentaccessdata.fda.gov
Counter, Differential CellGKZ2Complaint file establishmentaccessdata.fda.gov
CyclosporineMKW2Complaint file establishmentaccessdata.fda.gov
DetergentJCB1Complaint file establishmentaccessdata.fda.gov
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical SpecimensPMT2Complaint file establishmentaccessdata.fda.gov
Diazo Colorimetry, BilirubinCIG2Complaint file establishmentaccessdata.fda.gov
Diluent, Blood CellGIF1Complaint file establishmentaccessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2Complaint file establishmentaccessdata.fda.gov
Drug Mixture Control MaterialsDIF1Complaint file establishmentaccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Complaint file establishmentaccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Complaint file establishmentaccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Complaint file establishmentaccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Complaint file establishmentaccessdata.fda.gov
Enzymatic Method, Alcohol Dehydrogenase, UltravioletDMT2Complaint file establishmentaccessdata.fda.gov
Enzymatic Method, AmmoniaJIF1Complaint file establishmentaccessdata.fda.gov
Enzymatic Method, CreatinineJFY2Complaint file establishmentaccessdata.fda.gov
Enzymatic, Carbon-DioxideKHS2Complaint file establishmentaccessdata.fda.gov
Enzyme Controls (Assayed And Unassayed)JJT1Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, CarbamazepineKLT2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, DigoxinKXT2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, DiphenylhydantoinDIP2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, GentamicinLCD2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total ThyroxineKLI2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUComplaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, PhenobarbitalDLZ2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, PropoxypheneJXN2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, QuinidineLBZ2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, TheophyllineKLS2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, TracrolimusMLM2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, Valproic AcidLEG2Complaint file establishmentaccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, CytomegalovirusLFZ2Complaint file establishmentaccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-SpecificLGC2Complaint file establishmentaccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, RubellaLFX2Complaint file establishmentaccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiLGD2Complaint file establishmentaccessdata.fda.gov
Enzyme Linked Immunoabsorption Assay, Treponema PallidumLIP2Complaint file establishmentaccessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1MXJ2Complaint file establishmentaccessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2MYF2Complaint file establishmentaccessdata.fda.gov
Ferritin, Antigen, Antiserum, ControlDBF2Complaint file establishmentaccessdata.fda.gov
Fixative, Alcohol ContainingLDZ1Complaint file establishmentaccessdata.fda.gov
Fluid, Diluting, White-CellGGJ1Complaint file establishmentaccessdata.fda.gov
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)LGR2Complaint file establishmentaccessdata.fda.gov
Fluorescence Polarization Immunoassay, TheophyllineLGS2Complaint file establishmentaccessdata.fda.gov
Fluorescent Immunoassay, TobramycinLCR2Complaint file establishmentaccessdata.fda.gov
Fluorometric Method, Cpk Or IsoenzymesJHX2Complaint file establishmentaccessdata.fda.gov
Fluorometric, CortisolJFT2Complaint file establishmentaccessdata.fda.gov
Galectin-3 In Vitro Diagnostic AssayOSX2Complaint file establishmentaccessdata.fda.gov
Gas Chromatography, MethamphetamineLAF2Complaint file establishmentaccessdata.fda.gov
General Purpose ReagentPPM1Complaint file establishmentaccessdata.fda.gov
Haptoglobin, Antigen, Antiserum, ControlDAD2Complaint file establishmentaccessdata.fda.gov
Hemoglobin A1c Test SystemPDJ2Complaint file establishmentaccessdata.fda.gov
Hepatitis A Test (Antibody And Igm Antibody)LOL2Complaint file establishmentaccessdata.fda.gov
Hexokinase, GlucoseCFR2Complaint file establishmentaccessdata.fda.gov
Iga, Antigen, Antiserum, ControlCZP2Complaint file establishmentaccessdata.fda.gov
Ige, Antigen, Antiserum, ControlDGC2Complaint file establishmentaccessdata.fda.gov
Igg, Antigen, Antiserum, ControlDEW2Complaint file establishmentaccessdata.fda.gov
Igm, Antigen, Antiserum, ControlDFT2Complaint file establishmentaccessdata.fda.gov
Immunoassay Method, Troponin SubunitMMI2Complaint file establishmentaccessdata.fda.gov
Indirect Copper Assay, CeruloplasminJFR2Complaint file establishmentaccessdata.fda.gov
Kit, Serological, Negative ControlMJY1Complaint file establishmentaccessdata.fda.gov
Kit, Serological, Positive ControlMJX1Complaint file establishmentaccessdata.fda.gov
Kit, Test, Alpha-Fetoprotein For Neural Tube DefectsLOK3Complaint file establishmentaccessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, HdlLBS1Complaint file establishmentaccessdata.fda.gov
Ldl & Vldl Precipitation, HdlLBR1Complaint file establishmentaccessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesCDT1Complaint file establishmentaccessdata.fda.gov
Lipase-Esterase, Enzymatic, Photometric, LipaseCHI1Complaint file establishmentaccessdata.fda.gov
Lipoprotein, Low-Density, Antigen, Antiserum, ControlDFC2Complaint file establishmentaccessdata.fda.gov
Mixture, Control, White-Cell And Red-Cell IndicesGLQ2Complaint file establishmentaccessdata.fda.gov
Mixture, Hematology Quality ControlJPK2Complaint file establishmentaccessdata.fda.gov
Multi-Analyte Controls UnassayedOHQ1Complaint file establishmentaccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Complaint file establishmentaccessdata.fda.gov
Myoglobin, Antigen, Antiserum, ControlDDR2Complaint file establishmentaccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Cpk Or IsoenzymesCGS2Complaint file establishmentaccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate DehydrogenaseCFJ2Complaint file establishmentaccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/SgptCKA1Complaint file establishmentaccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/SgotCIT2Complaint file establishmentaccessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesCJE2Complaint file establishmentaccessdata.fda.gov
Ovarian Adnexal Mass Assessment Score Test SystemONX2Complaint file establishmentaccessdata.fda.gov
Ph BufferJCC1Complaint file establishmentaccessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic PhosphorusCEO1Complaint file establishmentaccessdata.fda.gov
Photometric Method, Iron (Non-Heme)JIY1Complaint file establishmentaccessdata.fda.gov
Photometric Method, MagnesiumJGJ1Complaint file establishmentaccessdata.fda.gov
Prealbumin, Antigen, Antiserum, ControlJZJ1Complaint file establishmentaccessdata.fda.gov
Procalcitonin AssayPRI2Complaint file establishmentaccessdata.fda.gov
Products, Red-Cell Lysing ProductsGGK1Complaint file establishmentaccessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate CancersLTJ2Complaint file establishmentaccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, MetalKWL2Complaint file establishmentaccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Complaint file establishmentaccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO2Complaint file establishmentaccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateMEH2Complaint file establishmentaccessdata.fda.gov
Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)JRS1Complaint file establishmentaccessdata.fda.gov
Qualitative And Quantitative Hepatitis B Virus Antibody AssaysSEI2Complaint file establishmentaccessdata.fda.gov
Radioassay, Triiodothyronine UptakeKHQ2Complaint file establishmentaccessdata.fda.gov
Radioassay, Vitamin B12CDD2Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, AmikacinKLQ2Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, C-Peptides Of ProinsulinJKD1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)JKC1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, EstradiolCHP1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating HormoneCGJ1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Free ThyroxineCEC2Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Immunoreactive InsulinCFP1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Luteinizing HormoneCEP1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Parathyroid HormoneCEW2Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, ProgesteroneJLS1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)CFT1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Testosterones And DihydrotestosteroneCDZ1Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, Total TriiodothyronineCDP2Complaint file establishmentaccessdata.fda.gov
Radioimmunoassay, VancomycinLEH2Complaint file establishmentaccessdata.fda.gov
Reagent, Coronavirus SerologicalQKONComplaint file establishmentaccessdata.fda.gov
Romanowsky StainsGJL1Complaint file establishmentaccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Complaint file establishmentaccessdata.fda.gov
Sirolimus Test SystemNRP2Complaint file establishmentaccessdata.fda.gov
Slide Stainer, AutomatedKPA1Complaint file establishmentaccessdata.fda.gov
Slides, MicroscopeKEW1Complaint file establishmentaccessdata.fda.gov
Stain, ReticulocyteGJH1Complaint file establishmentaccessdata.fda.gov
System, Test, Beta-2-Microglobulin ImmunologicalJZG2Complaint file establishmentaccessdata.fda.gov
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic CancerNIG2Complaint file establishmentaccessdata.fda.gov
System, Test, Carcinoembryonic AntigenDHX2Complaint file establishmentaccessdata.fda.gov
System, Test, Human Chorionic GonadotropinDHA2Complaint file establishmentaccessdata.fda.gov
System, Test, Immunological, Antigen, TumorMOI2Complaint file establishmentaccessdata.fda.gov
System, Test, Rheumatoid FactorDHR2Complaint file establishmentaccessdata.fda.gov
System, Test, Thyroid AutoantibodyJZO2Complaint file establishmentaccessdata.fda.gov
System, Test, Vitamin DMRG2Complaint file establishmentaccessdata.fda.gov
Test, Cystatin CNDY2Complaint file establishmentaccessdata.fda.gov
Test, Epithelial Ovarian Tumor Associated Antigen (He4)OIU2Complaint file establishmentaccessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)LTK2Complaint file establishmentaccessdata.fda.gov
Test, Equipment, Automated Bloodborne PathogenMZANComplaint file establishmentaccessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2Complaint file establishmentaccessdata.fda.gov
Test, Hiv DetectionMZF2Complaint file establishmentaccessdata.fda.gov
Test, Natriuretic PeptideNBC2Complaint file establishmentaccessdata.fda.gov
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign ConditionsMTG3Complaint file establishmentaccessdata.fda.gov
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate CancerMTF3Complaint file establishmentaccessdata.fda.gov
Transferrin, Antigen, Antiserum, ControlDDG2Complaint file establishmentaccessdata.fda.gov
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)JIQ1Complaint file establishmentaccessdata.fda.gov
Turbidimetric, Total ProteinJGQ2Complaint file establishmentaccessdata.fda.gov
U.V. Spectrometry, Tricyclic Antidepressant DrugsLFH2Complaint file establishmentaccessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea NitrogenCDQ2Complaint file establishmentaccessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test SystemLPS2Complaint file establishmentaccessdata.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 218.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 23, 2026K262156Anti-HCV NextMZOSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
April 28, 2026K252424Anti-HCV NextMZOSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
October 24, 2025K252357Glucose2CFRSubstantially EquivalentAbbott Irelandaccessdata.fda.gov
July 9, 2025K243500ARCHITECT iGentamicinLCDSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
June 20, 2025K243168Alinity i Rubella IgGLFXSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
May 16, 2025K242585Cystatin CNDYSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
February 20, 2025K243283Alinity h-series SystemGKZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
February 12, 2025K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsMYFSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
August 30, 2024K233932Alinity i Toxo IgMLGDSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
July 31, 2024K233541ARCHITECT Active-B12 (Holotranscobalamin)CDDSubstantially EquivalentAxis-Shield Diagnostics, Ltd.accessdata.fda.gov
November 17, 2023K231020Alinity c Tricyclic Antidepressants Reagent KitLFHSubstantially EquivalentMicrogenics Corporationaccessdata.fda.gov
September 29, 2023K232669TBIQATSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
September 20, 2023K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsMXJSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
August 10, 2023K222850HAVAb IgG IILOLSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
August 4, 2023K220031Alinity h-series SystemGKZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
July 21, 2023K223317Alkaline Phosphatase2CJESubstantially EquivalentAbbott Ireland Diagnostics Divisionaccessdata.fda.gov
June 5, 2023K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHASubstantially EquivalentAbbott Laboratoriesaccessdata.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
May 4, 2023K230994Alinity i STAT High Sensitivity Troponin-IMMISubstantially EquivalentAbbott Laboratories Diagnostics Divisionaccessdata.fda.gov
March 2, 2023K223602Traumatic brain injury (TBI) testQATSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
February 21, 2023K214068Quantia IgEDGCSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
December 29, 2022K223324Total Bilirubin2CIGSubstantially EquivalentAbbott Ireland Diagnostics Divisionaccessdata.fda.gov
October 27, 2022K220949Architect CMV IgGLFZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
June 30, 2022K203597Cholesterol2CHHSubstantially EquivalentAbbott Ireland Diagnostics Divisionaccessdata.fda.gov
May 26, 2022K210633Amylase2JFJSubstantially EquivalentAbbott Ireland Diagnostics Divisionaccessdata.fda.gov
May 19, 2022K210596ARCHITECT Toxo IgGLGDSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
May 19, 2022K202525Alinity i STAT High Sensitivity Troponin-IMMISubstantially EquivalentAbbott Laboratories Diagnostics Divisionaccessdata.fda.gov
March 22, 2022K210452Creatinine2CGXSubstantially EquivalentAbbott Ireland Diagnostics Divisionaccessdata.fda.gov
March 18, 2022K203530Albumin BCP2CJWSubstantially EquivalentAbbott Ireland Diagnostics Divisionaccessdata.fda.gov
March 10, 2022K213486GLP systems TrackJGSSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
February 18, 2022K202644AcetaminophenLDPSubstantially EquivalentSekisui Diagnostics P.E.I., Inc.accessdata.fda.gov
November 23, 2021K203248Albumin BCG2CIXSubstantially EquivalentAbbott Ireland Diagnostics Divisionaccessdata.fda.gov
November 8, 2019K192118CRP VarioDCKSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
September 13, 2019K191595ARCHITECT STAT High Sensitivity Troponin-IMMISubstantially EquivalentAbbott Laboratories Diagnostics Divisionaccessdata.fda.gov
March 15, 2019K190294CELL-DYN Emerald 22 AL SystemGKZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
September 27, 2018K173833CRP VarioNQDSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
September 12, 2018K181748MagnesiumJGJSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
July 6, 2018K181499DRI Cocaine Metabolite AssayDIOSubstantially EquivalentMicrogenics Corporationaccessdata.fda.gov
February 21, 2018K173963DRI Benzodiazepine AssayJXMSubstantially EquivalentMicrogenics Corporationaccessdata.fda.gov
October 27, 2017K173122Abbott Architect Free T4CECSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
October 24, 2017K170320Alinity c ICT Sample DiluentCGZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
October 23, 2017K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemDHASubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
October 19, 2017K170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMCFRSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
June 1, 2017K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlsPRISubstantially EquivalentFisher Diagnosticsaccessdata.fda.gov
March 31, 2017K162530Multichem IA PlusJJYSubstantially EquivalentTechno-Path Manufacturingaccessdata.fda.gov
February 15, 2017K170160Abbott ARCHITECT Free T3JITSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
October 26, 2016K162514Multichem A1cJJXSubstantially EquivalentTechnopath Manufacturingaccessdata.fda.gov
August 12, 2016K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 ControlsMRGSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
June 15, 2016K153730ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP ControlLIPSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
April 28, 2016K151502ARCHITECT ROMAONXSubstantially EquivalentFujirebio Diagnostics,Inc.accessdata.fda.gov
December 17, 2015K152155ARCHITECT 2nd Generation TestosteroneCDZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
July 10, 2015K151566Abbott ARCHITECT Total T4 CalibratorsJITSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
May 22, 2015K140654Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c ControlsPDJSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
April 2, 2015K150510Total BilirubinCIGSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
December 23, 2014K140436ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLSOSXSubstantially EquivalentFujirebio Diagnostics,Inc.accessdata.fda.gov
February 28, 2014K130255HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLSPDJSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
December 19, 2013K132400LP(A) CALIBRATORS, AND LP(A) CONTROLSJITSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
October 22, 2013K132751MULTICHEM S PLUS / S PLUS (ASSAYED)JJYSubstantially EquivalentTechno-Path Manufacturing , Ltd.accessdata.fda.gov
October 15, 2013K131993MULTICHEM UJJYSubstantially EquivalentTechno-Path Manufacturing , Ltd.accessdata.fda.gov
September 25, 2013K131992MULTICHEM PJJYSubstantially EquivalentTechno-Path Manufacturing , Ltd.accessdata.fda.gov
September 20, 2013K132174MULTICHEM WBTDIFSubstantially EquivalentTechno-Path Manufacturing , Ltd.accessdata.fda.gov
September 20, 2013K132091MULTICHEM IA AND IA PLUSJJYSubstantially EquivalentTechno-Path Manufacturing , Ltd.accessdata.fda.gov
August 29, 2013K123947ARCHITECT IVANCOMYCINLEHSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
June 5, 2013K123518ABBOTT CARBAMAZEPINE ASSAYKLTSubstantially EquivalentMicrogenics Corporationaccessdata.fda.gov
April 26, 2013K123271ABBOTT PHENOBARBITAL ASSAYDLZSubstantially EquivalentMicrogenics Corp.accessdata.fda.gov
February 1, 2013K121985ARCHITECT TOTAL BILIRUBINCIGSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
January 14, 2013K123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORJIXSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
November 27, 2012K123379ABBOTT ARCHITECT FREE T4CECSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
September 11, 2012K120009TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)CDZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
June 28, 2012K113704ARCHITECT HAVAB-GLOLSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
May 17, 2012K121314ARCHITECT B12CDDSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
December 22, 2011K111211CELL-DYN 22 PLUS CONTROLGLQSubstantially EquivalentStreckaccessdata.fda.gov
December 22, 2011K111204CELL-DYN 22 PLUS CALIBRATORKRXSubstantially EquivalentStreckaccessdata.fda.gov
December 22, 2011K110381CELL-DYN EMERALD 22 SYSTEMGKZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
December 19, 2011K112443ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)CDDSubstantially EquivalentAxis-Shield Diagnostics, Ltd.accessdata.fda.gov
October 14, 2011K103627ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORSKLTSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
June 10, 2011K111023ABBOTT ARCHITECT LH CALIBRATORSJITSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
May 6, 2011K102568URIC ACID MODEL 3P39KNKSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
April 1, 2011K102699ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORSLCDSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
February 4, 2011K103403MULTICONSTITUENT CALIBRATORJIXSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
May 12, 2010K093114THERMO SCIENTIFIC DRI AMPHETAMINES ASSAYDKZSubstantially EquivalentMicrogenics Corp.accessdata.fda.gov
March 18, 2010K093957ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,OIUSubstantially EquivalentFujirebio Diagnostics,Inc.accessdata.fda.gov
March 5, 2010K092740ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74CGNSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
February 19, 2010K093318ACCELERATOR APSCEMSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
September 25, 2009K083868ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35NHXSubstantially EquivalentAxis-Shield Diagnostics, Ltd.accessdata.fda.gov
August 6, 2009K090358ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35LEGSubstantially EquivalentAbbott Laboratories, Inc.accessdata.fda.gov
April 7, 2009K083809CREATININECGXSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
February 4, 2009K081495CELL-DYN EMERALD SYSTEMGKZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
December 22, 2008K082953ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01KXTSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
September 26, 2008K081231ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33DLZSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
September 11, 2008K080751ARCHITECT CYCLOSPORINEMKWSubstantially EquivalentFujirebio Diagnostics,Inc.accessdata.fda.gov
September 11, 2008K080696ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01DIPSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
September 3, 2008K082141ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10JITSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
June 19, 2008K073634MULTIGENT CREATININE (ENZYMATIC) ASSAYJFYSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov
April 30, 2008K080085MAS TOX CONTROLDIFSubstantially EquivalentThermo Fisher Scientificaccessdata.fda.gov
April 24, 2008K073640ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLSLPSSubstantially EquivalentAxis-Shield Diagnostics, Ltd.accessdata.fda.gov
March 19, 2008K072036ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01LEHSubstantially EquivalentBiokit, S.A.accessdata.fda.gov
March 19, 2008K071525ACTIVATED ASPARTATE AMINOTRANSFERASECITSubstantially EquivalentAbbott Laboratoriesaccessdata.fda.gov
September 28, 2007K070822ARCHITECT SIROLIMUS ASSAYNRPSubstantially EquivalentFujirebio Diagnostics,Inc.accessdata.fda.gov
August 2, 2007K070987SENTINEL LITHIUM ASSAYNDWSubstantially EquivalentSENTINEL CH. SpAaccessdata.fda.gov

PMA approvals

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

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
August 10, 2022P210003ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT QualitLOM13April 3, 2025accessdata.fda.gov
November 28, 2012P120008ABBOTT ARCHITECT AFP ASSAYLOK32May 11, 2026accessdata.fda.gov
April 12, 2012P110029ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLSLOM51April 3, 2025accessdata.fda.gov
April 10, 2009P080023ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLSSEI46April 3, 2025accessdata.fda.gov
November 6, 2007P060035ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLSSEI43April 3, 2025accessdata.fda.gov
June 7, 2006P050042ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROLMZO47December 15, 2021accessdata.fda.gov
June 1, 2006P050051ABBOTT ARCHITECT AUSABSEI60April 3, 2025accessdata.fda.gov
February 5, 2004P980007AXSYM FREE PSAMTG55February 12, 2026accessdata.fda.gov
September 25, 1991P910007AXSYM TOTAL PSA & ARCHITECT TOTAL PSAMTF67February 23, 2026accessdata.fda.gov

Compare with other makers

Updated September 23, 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.