Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GTP — 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) |
|---|---|---|---|---|---|
| K860041 | STREP D FLUOR | Bio Spec, Inc. | 1986-01-24 | 18 | 0 |
| K833738 | LEAP STREP TEST KIT | Cooper Biomedical, Inc. | 1983-12-27 | 63 | 0 |
| K822799 | STREPTACOCCUS CO-AGGLUTINATION KIT | American Scientific Products | 1982-12-19 | 94 | 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