COZART EIA COTININE URINE KIT— 510(k) K021944

Name: FDA 510(k) clearance K021944
Creator: U.S. Food and Drug Administration
Published: 2003-05-14

Substantially Equivalent

Cozart Bioscience , Ltd.

FDA 510(k) clearance K021944 for COZART EIA COTININE URINE KIT, Substantially Equivalent on 2003-05-14. Applicant: Cozart Bioscience , Ltd.. Device class: 1.

Clearance details

Applicant: Cozart Bioscience , Ltd.
Product code: Code MKU
Device class: Class 1
Regulation: 21 CFR 862.3220
Advisory panel: Clinical Toxicology
Date received: 2002-06-13
Decision date: 2003-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxfordshire Ox14 4ru, GB

Download summary PDF View on FDA.gov ↗

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