Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JJA — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K820253 | SIMUL-FER SERUM IRON TEST KIT | Diagnostic Reagents, Inc. | 1982-05-12 | 103 | 0 |
| K782159 | DIAGNOSTIC KIT, FERRITAB-FE-59 | Leeco Diagnostics, Inc. | 1979-02-01 | 41 | 0 |
| K781769 | IRON 59 KIT | Ria Products, Inc. | 1978-12-04 | 49 | 0 |
| K760045 | KIT, RADIOASSAY, SERUM IRON | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-07-20 | 35 | 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