Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clinical Bioresearch — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K780707 | T4-RIA KIT | Clinical Bioresearch | 1978-06-14 | 50 | 0 |
| K780499 | CBR-T3RIA KIT | Clinical Bioresearch | 1978-05-04 | 37 | 0 |
| K780500 | CBR-T3 UPTAKE KIT | Clinical Bioresearch | 1978-05-03 | 36 | 0 |
| K780498 | CBR-DIGOXIN ANTISERUM | Clinical Bioresearch | 1978-04-05 | 8 | 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