Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LGJ — 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) |
|---|---|---|---|---|---|
| K991597 | COBAS INTEGRA AMIKACIN MAB | Roche Diagnostics Corp. | 1999-07-22 | 73 | 0 |
| K941712 | COBAS-FP REAGENTS AND CALIBRATORS | Roche Diagnostic Systems, Inc. | 1994-06-13 | 68 | 0 |
| K862248 | AMIKACIN KIT (FPIA) | Windsor Laboratories, Inc. | 1986-08-04 | 53 | 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