Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Bay Area Hema. Onco. Clinic. & Res. L · 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) |
|---|---|---|---|---|---|
| K771678 | THROMBO-SCREEN PLATELET ADHESION | Bay Area Hema. Onco. Clinic. & Res. L | 1977-11-22 | 81 | 0 |
| K770722 | THROMBO SCREEN QUANTITATIVE HEPARIN ASSA | Bay Area Hema. Onco. Clinic. & Res. L | 1977-07-11 | 83 | 0 |
| K770394 | THROMBO-SCREEN AT-111 KIT | Bay Area Hema. Onco. Clinic. & Res. L | 1977-03-30 | 30 | 0 |
| K770395 | THROMBO-CETIN (RISTOCETIN) | Bay Area Hema. Onco. Clinic. & Res. L | 1977-03-21 | 21 | 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