Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diagnostica Stago · 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) |
|---|---|---|---|---|---|
| K162227 | STA® - Liatest® D-Di | Diagnostica Stago | 2016-12-10 | 124 | 2 |
| K141144 | STA LIATEST D-DI | Diagnostica Stago | 2014-09-03 | 124 | 1 |
| K010455 | ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN | Diagnostica-Stago | 2001-06-07 | 129 | 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