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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas Chromatography, Methamphetamine
510(k) Number K133047
Device Name RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU
Applicant
Biophor Diagnostics, Inc.
1201 Douglas Ave.
Redwood City,  CA  94063
Applicant Contact Nathaniel G Butlin
Correspondent
Biophor Diagnostics, Inc.
1201 Douglas Ave.
Redwood City,  CA  94063
Correspondent Contact Nathaniel G Butlin
Regulation Number862.3610
Classification Product Code
LAF  
Subsequent Product Codes
DIF   DLJ  
Date Received09/27/2013
Decision Date 12/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
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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