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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, Opiates
510(k) Number K020920
Device Name COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE
Applicant
Cozart Bioscience , Ltd.
45 Milton Park
Abingdon
Oxfordshire Ox14 4ru,  GB OX14 4RU
Applicant Contact ROBERTO LIDDI
Correspondent
Cozart Bioscience , Ltd.
45 Milton Park
Abingdon
Oxfordshire Ox14 4ru,  GB OX14 4RU
Correspondent Contact ROBERTO LIDDI
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Code
DJR  
Date Received03/21/2002
Decision Date 11/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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