Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bayer Healthcare, Diagnostics Division · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042015 | ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GL | Bayer Healthcare, Diagnostics Division | 2004-09-29 | 64 | 0 |
| K033643 | CO2 CALIBRATOR/DILUENT | Bayer Healthcare, Diagnostics Division | 2004-01-08 | 49 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda