Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Olympus Diagnostica GmbH · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K994189 | OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 | Olympus Diagnostica GmbH | 2000-01-20 | 38 | 0 |
| K984145 | OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT | Olympus Diagnostica GmbH | 1998-12-23 | 34 | 0 |
| K981854 | OLYMPUS SERUM PROTEIN MULTICALIBRATOR, | Olympus Diagnostica GmbH | 1998-08-18 | 84 | 0 |
| K982035 | OLYMPUS CALCIUM ARSENAZO III REAGENT | Olympus Diagnostica GmbH | 1998-06-24 | 14 | 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