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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 K191638
Device Name Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
Applicant
Medtest DX
5449 Research Dr.
Lincoln Park,  MI  48188
Applicant Contact William Cripps
Correspondent
Medtest DX
5449 Research Dr.
Lincoln Park,  MI  48188
Correspondent Contact William Cripps
Regulation Number862.3250
Classification Product Code
DIO  
Date Received06/19/2019
Decision Date 03/12/2020
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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