Bayer Diagnostics Corp.
Medfield, MA, US
Bayer Diagnostics Corp. appears in FDA device records in Medfield, MA. FDA records list 32 510(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
- 32
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 32 510(k) clearances for Bayer Diagnostics Corp. between 2000 and 2003. The busiest year on record is 2002, with 19. The most recent is 2003, with 7.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 5 |
| 2002 | 19 |
| 2003 | 7 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K033379 | BAYER SPECIAL CHEMISTRY CONTROLS | JJY | Substantially Equivalent | |
| K033380 | BAYER SPECIAL CHEMISTRY CALIBRATORS | JIX | Substantially Equivalent | |
| K033007 | BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM | KXT | Substantially Equivalent | |
| K031857 | ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY | DEM | Substantially Equivalent | |
| K022096 | URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | KNK | Substantially Equivalent | |
| K030452 | BAYER LIGAND PLUS 1, 2, 3 CONTROLS | JJY | Substantially Equivalent | |
| K023840 | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 | CKB | Substantially Equivalent | |
| K023841 | AMMONIA ASSAY FOR THE ADVIA 1650 | JIF | Substantially Equivalent | |
| K022177 | PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | LTJ | Substantially Equivalent | |
| K022329 | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | LTK | Substantially Equivalent | |
| K023184 | ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | DIC | Substantially Equivalent | |
| K022178 | CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | MOI | Substantially Equivalent | |
| K022668 | ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD | GKZ | Substantially Equivalent | |
| K020807 | AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | LOJ | Substantially Equivalent | |
| K022968 | ADVIA TESTPOINT CSF CONTROL | JPK | Substantially Equivalent | |
| K022331 | ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD | GKL | Substantially Equivalent | |
| K020616 | BAYER RAPIDPOINT 405 SYSTEM | GKR | Substantially Equivalent | |
| K021151 | AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | JIF | Substantially Equivalent | |
| K020794 | SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | DKJ | Substantially Equivalent | |
| K020792 | ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | LDP | Substantially Equivalent | |
| K021535 | ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR | JIT | Substantially Equivalent | |
| K021532 | ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR | JIT | Substantially Equivalent | |
| K020217 | ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY | JJX | Substantially Equivalent | |
| K012357 | CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM | MOI | Substantially Equivalent | |
| K013959 | BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS | DKB | Substantially Equivalent | |
| K013750 | ADVIA 1650 CHOLINESTERASE ASSAY | DIH | Substantially Equivalent | |
| K012183 | BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY | LGD | Substantially Equivalent | |
| K013606 | ACS 180 HOMOCYSTEINE ASSAY | LPS | Substantially Equivalent | |
| K013406 | ADVIA CENTAUR HOMOCYSTEINE ASSAY | LPS | Substantially Equivalent | |
| K012904 | ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION | GKZ | Substantially Equivalent | |
| K010050 | ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY | CGN | Substantially Equivalent | |
| K003291 | BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY | JZO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CKBAcid Phosphatase, Naphthyl Phosphate
- CGNAcid, Folic, Radioimmunoassay
- KNKAcid, Uric, Uricase (Colorimetric)
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- DKBCalibrators, Drug Mixture
- LDPColorimetry, Acetaminophen
- DIHColorimetry, Cholinesterase
- DKJColorimetry, Salicylate
- GKLCounter, Cell, Automated (Particle Counter)
- GKZCounter, Differential Cell
- JIFEnzymatic Method, Ammonia
- KXTEnzyme Immunoassay, Digoxin
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LOJKit, Test,Alpha-Fetoprotein For Testicular Cancer
- JPKMixture, Hematology Quality Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- GKRSystem, Hemoglobin, Automated
- MOISystem, Test, Immunological, Antigen, Tumor
- JZOSystem, Test, Thyroid Autoantibody
- LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
- LPSUrinary Homocystine (Nonquantitative) Test System
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