Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GTH · 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) |
|---|---|---|---|---|---|
| K900546 | BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT | Baxter Healthcare Corp | 1990-06-15 | 130 | 0 |
| K861835 | MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST | Syva Co. | 1986-05-29 | 16 | 0 |
| K800328 | NEISSERIA GONORRHOEAE FLUORO-KIT | Clinical Sciences, Inc. | 1980-03-03 | 20 | 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