Cleared Traditional

COZART EIA OPIATES ORAL FLUID KIT

K024339 · Cozart Bioscience , Ltd. · Toxicology

Apr 2003

Decision

101d

Days

Class 1

Risk

About This 510(k) Submission

K024339 is an FDA 510(k) clearance for the COZART EIA OPIATES ORAL FLUID KIT, a Cholinesterase Test Paper (Class I — General Controls, product code DIG), submitted by Cozart Bioscience , Ltd. (Oxfordshire Ox14 4ru, GB). The FDA issued a Cleared decision on April 7, 2003, 101 days after receiving the submission on December 27, 2002. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number	K024339 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2002
Decision Date	April 07, 2003
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement