Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DLN · 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) |
|---|---|---|---|---|---|
| K950134 | URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE | E.I. Dupont DE Nemours & Co., Inc. | 1995-03-21 | 67 | 0 |
| K924113 | ABUSCREEN ONLINE FOR COCAINE METABOLITE | Roche Diagnostic Systems, Inc. | 1992-12-28 | 137 | 0 |
| K792429 | HIM TEST COCAINE | Tecknam, Inc. | 1979-12-07 | 9 | 0 |
| K760401 | COCAINE KIT, TOXI-PAK | J.T. Baker Chemical Co. | 1976-08-26 | 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