Bayer Diagnostics Corp.: FDA clearances and approvals
Bayer Diagnostics Corp. has 32 FDA 510(k) clearances (first 2000, latest 2003), across 26 product codes in 5 review panels. Median 510(k) review time: 59 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 2 | 2 |
| JIF | Enzymatic Method, Ammonia | 2 | 2 |
| JIT | Calibrator, Secondary | 2 | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | 2 | 2 |
| MOI | System, Test, Immunological, Antigen, Tumor | 2 | 2 |
| CGN | Acid, Folic, Radioimmunoassay | 1 | 1 |
| CKB | Acid Phosphatase, Naphthyl Phosphate | 1 | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 | 1 |
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 1 | 1 |
Plus 16 more product codes.
Review panels
- Clinical Chemistry (13)
- Immunology (7)
- Clinical Toxicology (6)
- Hematology (5)
- Microbiology (1)
Most recent Bayer Diagnostics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033379 | BAYER SPECIAL CHEMISTRY CONTROLS | JJY | 2003-12-19 | 58 |
| K033380 | BAYER SPECIAL CHEMISTRY CALIBRATORS | JIX | 2003-12-16 | 55 |
| K033007 | BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM | KXT | 2003-11-14 | 49 |
| K031857 | ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY | DEM | 2003-09-04 | 80 |
| K022096 | URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | KNK | 2003-03-18 | 264 |
| K030452 | BAYER LIGAND PLUS 1, 2, 3 CONTROLS | JJY | 2003-03-03 | 20 |
| K023840 | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 | CKB | 2003-01-07 | 50 |
| K023841 | AMMONIA ASSAY FOR THE ADVIA 1650 | JIF | 2002-12-24 | 36 |
| K022177 | PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | LTJ | 2002-12-17 | 167 |
| K022329 | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | LTK | 2002-11-27 | 132 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bayer Diagnostics Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bayer Diagnostics Corp. have?
Bayer Diagnostics Corp. has 32 FDA 510(k) clearances (first 2000, latest 2003), across 26 product codes in 5 review panels.
How long does FDA take to clear Bayer Diagnostics Corp.'s 510(k)s?
The median time from FDA receipt to decision across Bayer Diagnostics Corp.'s cleared 510(k)s is 59 days.
What devices does Bayer Diagnostics Corp. make?
Its most frequent FDA product codes are GKZ (Counter, Differential Cell, 2); JIF (Enzymatic Method, Ammonia, 2); JIT (Calibrator, Secondary, 2).
Has Bayer Diagnostics Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bayer Diagnostics Corp. Related entities may recall under other names.
Next steps
- See all 32 Bayer Diagnostics Corp. clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Bayer Diagnostics Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.