Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eurodiagnostica — 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) |
|---|---|---|---|---|---|
| K052133 | IMMUNOSCAN RA ANTI-CCP TEST SYSTEM | Eurodiagnostica | 2005-12-12 | 129 | 0 |
| K051455 | WIESLAB CAP MPO-ANCA | Eurodiagnostica | 2005-11-23 | 174 | 0 |
| K051458 | WIESLAB CAP PR-3 ANCA | Eurodiagnostica | 2005-11-22 | 173 | 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