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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K033743
Device Name COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT
Applicant
Cozart Bioscience , Ltd.
45 Milton Park
Abingdon,Oxfordshire,  GB OX14 4RU
Applicant Contact ROBERTO LIDDI
Correspondent
Cozart Bioscience , Ltd.
45 Milton Park
Abingdon,Oxfordshire,  GB OX14 4RU
Correspondent Contact ROBERTO LIDDI
Regulation Number862.3100
Classification Product Code
DKZ  
Date Received11/28/2003
Decision Date 06/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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