Cleared Traditional

COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT

K033743 · Cozart Bioscience , Ltd. · Toxicology
Jun 2004
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K033743 is an FDA 510(k) clearance for the COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Cozart Bioscience , Ltd. (Abingdon,Oxfordshire, GB). The FDA issued a Cleared decision on June 3, 2004, 188 days after receiving the submission on November 28, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K033743 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2003
Decision Date June 03, 2004
Days to Decision 188 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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