Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DDQ · 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) |
|---|---|---|---|---|---|
| K972257 | N-ASSAY TIA ANTITHROMBIN III TEST KIT | Crestat Diagnostics, Inc. | 1997-10-20 | 125 | 0 |
| K935307 | DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA | Baxter Diagnostics, Inc. | 1994-11-22 | 385 | 0 |
| K932713 | TRACE TRANSFERRIN REAGENT | Trace Scientific , Ltd. | 1993-09-30 | 118 | 0 |
| K780012 | ANTITHROMBIN III RIA | Ria Diagnostics | 1978-01-20 | 17 | 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