Cozart Bioscience , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Cozart Bioscience , Ltd.” (first 2001, latest 2004), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 148 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DIG | Cholinesterase Test Paper | 1 | 1 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| DJR | Enzyme Immunoassay, Methadone | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| MKU | Enzyme Immunoassay, Nicotine And Nicotine Metabolites | 1 | 1 |
Review panels
Most recent Cozart Bioscience , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033743 | COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT | DKZ | 2004-06-03 | 188 |
| K021944 | COZART EIA COTININE URINE KIT | MKU | 2003-05-14 | 335 |
| K030234 | COZART EIA COCAINE ORAL FLIUD KIT | DIO | 2003-04-28 | 95 |
| K024339 | COZART EIA OPIATES ORAL FLUID KIT | DIG | 2003-04-07 | 101 |
| K020920 | COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE | DJG | 2002-11-05 | 229 |
| K011131 | METHADONE MICROPLATE EIA URINE APPLICATION | DJR | 2001-07-31 | 109 |
Recalls
openFDA lists no recalls under a recalling firm named Cozart Bioscience , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cozart Bioscience , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Cozart Bioscience , Ltd.” (first 2001, latest 2004), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cozart Bioscience , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cozart Bioscience , Ltd. is 148 days.
Which FDA product codes appear under Cozart Bioscience , Ltd.?
The most frequent FDA product codes under this applicant name are DIG (Cholinesterase Test Paper, 1); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 1); DJG (Enzyme Immunoassay, Opiates, 1).
Next steps
- See all 6 Cozart Bioscience , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DIG, Cozart Bioscience , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.