Bayer Corp.
Tarrytown, NY, US
Bayer Corp. appears in FDA device records in Tarrytown, NY. FDA records list 63 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 63
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 63FDA records hold 63 510(k) clearances for Bayer Corp. between 1995 and 2003. The busiest year on record is 1996, with 14. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 3 |
| 1996 | 14 |
| 1997 | 11 |
| 1998 | 7 |
| 1999 | 10 |
| 2000 | 6 |
| 2001 | 8 |
| 2002 | 3 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K024017 | BAYER ADVIA CENTAUR HER-2/NEU ASSAY | NCW | Substantially Equivalent | |
| K022288 | COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | LTJ | Substantially Equivalent | |
| K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM | LTK | Substantially Equivalent | |
| K021428 | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM | JFY | Substantially Equivalent | |
| K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | DHX | Substantially Equivalent | |
| K012337 | BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM | DCN | Substantially Equivalent | |
| K011963 | ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY | CFR | Substantially Equivalent | |
| K013272 | ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY | KLS | Substantially Equivalent | |
| K012777 | ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS | JZO | Substantially Equivalent | |
| K012340 | BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) | JMO | Substantially Equivalent | |
| K010201 | BAYER ADVIA IMS SYSTEM | MMI | Substantially Equivalent | |
| K003796 | ADVIA 120 HEMATOLOGY | GKZ | Substantially Equivalent | |
| K992228 | BAYER IMMUNO 1 HER-2/NEU ASSAY | NCW | Substantially Equivalent | |
| K001344 | ADVIA IMS | DIH | Substantially Equivalent | |
| K000921 | BAYER ADVIA IMS SYSTEM; 200 + 3 | DER | Substantially Equivalent | |
| K000903 | ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM | KLT | Substantially Equivalent | |
| K993867 | BAYER ADVIA IMS SYSTEM | CIG | Substantially Equivalent | |
| K992662 | 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM | MSJ | Substantially Equivalent | |
| K993711 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) | JZG | Substantially Equivalent | |
| K993353 | TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) | MMI | Substantially Equivalent | |
| K992136 | BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) | CIT | Substantially Equivalent | |
| K991907 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | CZW | Substantially Equivalent | |
| K992399 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | CIX | Substantially Equivalent | |
| K991817 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | CIJ | Substantially Equivalent | |
| K991576 | ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM | CIX | Substantially Equivalent | |
| K990346 | BAYER ADVIA 1650 CHEMISTRY SYSTEM | JGS | Substantially Equivalent | |
| K983715 | THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | LTK | Substantially Equivalent | |
| K982328 | BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | CJO | Substantially Equivalent | |
| K983345 | BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY | JJE | Substantially Equivalent | |
| K982714 | BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY | DBF | Substantially Equivalent | |
| K982802 | BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | GKZ | Substantially Equivalent | |
| K981312 | 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | JLW | Substantially Equivalent | |
| K980376 | THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | LTJ | Substantially Equivalent | |
| K980521 | DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS | KXT | Substantially Equivalent | |
| K974721 | UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | CGI | Substantially Equivalent | |
| K973616 | TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | MMI | Substantially Equivalent | |
| K964703 | THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | MOI | Substantially Equivalent | |
| K964098 | CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | LTK | Substantially Equivalent | |
| K971989 | TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | LGD | Substantially Equivalent | |
| K972580 | DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | JMM | Substantially Equivalent | |
| K972462 | AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | LOJ | Substantially Equivalent | |
| K971998 | ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM | GKL | Substantially Equivalent | |
| K971716 | PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | LAR | Substantially Equivalent | |
| K971713 | N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | LAN | Substantially Equivalent | |
| K964791 | B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | JZG | Substantially Equivalent | |
| K964587 | VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM | LEH | Substantially Equivalent | |
| K964116 | QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | LBZ | Substantially Equivalent | |
| K964442 | VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | LEG | Substantially Equivalent | |
| K964068 | CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | KLT | Substantially Equivalent | |
| K963080 | TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) | CDZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CGNAcid, Folic, Radioimmunoassay
- DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control
- CJOAlpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- MSJApolipoproteins
- LCPAssay, Glycosylated Hemoglobin
- CIXBromcresol Green Dye-Binding, Albumin
- JHYColorimetric Method, Cpk Or Isoenzymes
- DIHColorimetry, Cholinesterase
- JMMColumn Chromatography & Color Development, Hydroxyproline
- CZWComplement C3, Antigen, Antiserum, Control
- GKLCounter, Cell, Automated (Particle Counter)
- GKZCounter, Differential Cell
- CIGDiazo Colorimetry, Bilirubin
- JGSElectrode, Ion Specific, Sodium
- JFYEnzymatic Method, Creatinine
- KLTEnzyme Immunoassay, Carbamazepine
- LFMEnzyme Immunoassay, Digitoxin
- KXTEnzyme Immunoassay, Digoxin
- LANEnzyme Immunoassay, N-Acetylprocainamide
- LAREnzyme Immunoassay, Procainamide
- LBZEnzyme Immunoassay, Quinidine
- KLSEnzyme Immunoassay, Theophylline
- LEGEnzyme Immunoassay, Valproic Acid
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- DBFFerritin, Antigen, Antiserum, Control
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- CFRHexokinase, Glucose
- MMIImmunoassay Method, Troponin Subunit
- LOJKit, Test,Alpha-Fetoprotein For Testicular Cancer
- DDRMyoglobin, Antigen, Antiserum, Control
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers
- CHPRadioimmunoassay, Estradiol
- CGIRadioimmunoassay, Estriol
- JLSRadioimmunoassay, Progesterone
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- LEHRadioimmunoassay, Vancomycin
- CIJSaccharogenic, Amylase
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- DCNSystem, Test, C-Reactive Protein
- DHXSystem, Test, Carcinoembryonic Antigen
- NCWSystem, Test, Her-2/Neu, Monitoring
- DHASystem, Test, Human Chorionic Gonadotropin
- MOISystem, Test, Immunological, Antigen, Tumor
- JZOSystem, Test, Thyroid Autoantibody
- LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain