Cleared Traditional

K030234 - COZART EIA COCAINE ORAL FLIUD KIT
(FDA 510(k) Clearance)

K030234 · Cozart Bioscience , Ltd. · Toxicology

Apr 2003

Decision

95d

Days

Class 2

Risk

K030234 is an FDA 510(k) clearance for the COZART EIA COCAINE ORAL FLIUD KIT, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Cozart Bioscience , Ltd. (Abingdon,Oxfordshire, GB). The FDA issued a Cleared decision on April 28, 2003, 95 days after receiving the submission on January 23, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number	K030234 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 2003
Decision Date	April 28, 2003
Days to Decision	95 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF