Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cozart Bioscience , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
188 daysmedian FDA review time
335 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033743 | COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT | Cozart Bioscience , Ltd. | 2004-06-03 | 188 | 0 |
| K021944 | COZART EIA COTININE URINE KIT | Cozart Bioscience , Ltd. | 2003-05-14 | 335 | 0 |
| K030234 | COZART EIA COCAINE ORAL FLIUD KIT | Cozart Bioscience , Ltd. | 2003-04-28 | 95 | 0 |
| K024339 | COZART EIA OPIATES ORAL FLUID KIT | Cozart Bioscience , Ltd. | 2003-04-07 | 101 | 0 |
| K020920 | COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE | Cozart Bioscience , Ltd. | 2002-11-05 | 229 | 0 |
| K011131 | METHADONE MICROPLATE EIA URINE APPLICATION | Cozart Bioscience , Ltd. | 2001-07-31 | 109 | 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