Bayer Healthcare, Diagnostics Division: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Bayer Healthcare, Diagnostics Division” (first 2004, latest 2004), plus 1 PMA decision, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 56 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Siemens Healthineers, based on public ownership records.
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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
| LOL | Hepatitis A Test (Antibody And Igm Antibody) | 1 | 0 |
Review panels
- Clinical Chemistry (2)
- Microbiology (1)
Most recent Bayer Healthcare, Diagnostics Division 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042015 | ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE | CGA | 2004-09-29 | 64 |
| K033643 | CO2 CALIBRATOR/DILUENT | JIT | 2004-01-08 | 49 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P040017 | PMA | ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS | 2005-03-07 |
Recalls
openFDA lists no recalls under a recalling firm named Bayer Healthcare, Diagnostics Division.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Bayer Corp. (96 510(k)s)
- Bayer Healthcare, LLC (55 510(k)s)
- Bayer Diagnostics Corp. (32 510(k)s)
- Bayer Medical Care, Inc. (10 510(k)s)
- Bayer Corp., Agfa Div. (3 510(k)s)
- Bayer Group Diagnostics (2 510(k)s)
- Bayer U.S., LLC (1 510(k)s)
- Bayer Pharma AG (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bayer Healthcare, Diagnostics Division?
FDA lists 2 510(k) clearances under the applicant name “Bayer Healthcare, Diagnostics Division” (first 2004, latest 2004), plus 1 PMA decision, across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bayer Healthcare, Diagnostics Division?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bayer Healthcare, Diagnostics Division is 56 days.
Which FDA product codes appear under Bayer Healthcare, Diagnostics Division?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 1); JIT (Calibrator, Secondary, 1); LOL (Hepatitis A Test (Antibody And Igm Antibody), 1).
Next steps
- See all 2 Bayer Healthcare, Diagnostics Division clearances with predicates and recalls
- Run predicate analysis for product code CGA, Bayer Healthcare, Diagnostics Division's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.