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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, Cocaine And Cocaine Metabolites
510(k) Number K030234
Device Name COZART EIA COCAINE ORAL FLIUD 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 Number862.3250
Classification Product Code
DIO  
Date Received01/23/2003
Decision Date 04/28/2003
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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