COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT— 510(k) K033743

Name: FDA 510(k) clearance K033743
Creator: U.S. Food and Drug Administration
Published: 2004-06-03

Substantially Equivalent

Cozart Bioscience , Ltd.

FDA 510(k) clearance K033743 for COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT, Substantially Equivalent on 2004-06-03. Applicant: Cozart Bioscience , Ltd.. Device class: 2.

Clearance details

Applicant: Cozart Bioscience , Ltd.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2003-11-28
Decision date: 2004-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abingdon,Oxfordshire, GB

Download summary PDF View on FDA.gov ↗

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