Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NIY · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113439 | EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG | Euroimmun US | 2013-04-12 | 508 | 0 |
| K112221 | EUROIMMUN ANTI-SLA/LP ELISA(LGG) | Euroimmun US | 2012-09-11 | 406 | 0 |
| K021482 | QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA | Inova Diagnostics, Inc. | 2002-07-30 | 83 | 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