Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GPW · 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) |
|---|---|---|---|---|---|
| K872700 | YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN | Sita, Inc. | 1987-10-15 | 100 | 0 |
| K843654 | CHLAMYDIA | Institute Virion , Ltd. | 1985-08-08 | 325 | 0 |
| K844868 | CHLAMYDIA GROUP CF ANTIGEN | Hillcrest Biologicals | 1985-03-05 | 81 | 0 |
| K811570 | ANTIBODY TO CHLAMYDIA TRACHOMATIS | Electro-Nucleonics Laboratories, Inc. | 1981-07-23 | 49 | 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