Cleared Traditional

COZART EIA COTININE URINE KIT

K021944 · Cozart Bioscience , Ltd. · Toxicology
May 2003
Decision
335d
Days
Class 1
Risk

About This 510(k) Submission

K021944 is an FDA 510(k) clearance for the COZART EIA COTININE URINE KIT, a Enzyme Immunoassay, Nicotine And Nicotine Metabolites (Class I — General Controls, product code MKU), submitted by Cozart Bioscience , Ltd. (Oxfordshire Ox14 4ru, GB). The FDA issued a Cleared decision on May 14, 2003, 335 days after receiving the submission on June 13, 2002. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3220.

Submission Details

510(k) Number K021944 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2002
Decision Date May 14, 2003
Days to Decision 335 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code MKU — Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3220

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