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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cholinesterase Test Paper
510(k) Number K024339
Device Name COZART EIA OPIATES ORAL FLUID KIT
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 Number862.3240
Classification Product Code
DIG  
Date Received12/27/2002
Decision Date 04/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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