Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Roche Diagnostics/Boehringer Mannheim GmbH — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983892 | COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO | Roche Diagnostics/Boehringer Mannheim GmbH | 1999-04-13 | 161 | 1 |
| K981931 | CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY | Roche Diagnostics/Boehringer Mannheim GmbH | 1998-08-25 | 84 | 0 |
| K981632 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBI | Roche Diagnostics/Boehringer Mannheim GmbH | 1998-06-15 | 38 | 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