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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 K142129
Device Name RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET
Applicant
Biophor Diagnostics, Inc.
1201 Douglas Ave.
Redwood City,  CA  94063
Applicant Contact NATAHANIEL G BUTLIN
Correspondent
Biophor Diagnostics, Inc.
1201 Douglas Ave.
Redwood City,  CA  94063
Correspondent Contact NATAHANIEL G BUTLIN
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DIF   DLJ  
Date Received08/04/2014
Decision Date 07/24/2015
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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