Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DAB · 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) |
|---|---|---|---|---|---|
| K913670 | HAPTOGLOBIN IMMUNOLOGICAL TEST KIT | The Binding Site, Ltd. | 1991-12-09 | 112 | 0 |
| K843570 | FIAX HAPTOGLOBIN TEST KIT | Intl. Diagnostic Technology | 1984-10-05 | 24 | 0 |
| K772078 | RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN | Gelman Instrument Co. | 1978-02-03 | 92 | 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