Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NBS · 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) |
|---|---|---|---|---|---|
| K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrator | Inova Diagnostics, Inc. | 2017-09-06 | 264 | 0 |
| K112223 | EUROIMMUN ANTI-LKM-1 ELISA(LGG) | Euroimmun US | 2012-09-11 | 406 | 0 |
| K000535 | QUANTA LITE LKM-1 ELISA | Inova Diagnostics, Inc. | 2000-06-07 | 111 | 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