Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LDN · 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) |
|---|---|---|---|---|---|
| K840647 | AMIKACIN REAGENT TEST KIT | Beckman Instruments, Inc. | 1984-04-02 | 47 | 0 |
| K833546 | MODIFICATION OF EMIT AND AMIKACIN ASSAY | Syva Co. | 1983-12-08 | 55 | 0 |
| K820440 | EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO | Syva Co. | 1982-03-15 | 26 | 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