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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, phencyclidine
510(k) Number K122703
Device Name RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR
Original Applicant
BIOPHOR DIAGNOSTICS, INC.
1201 douglas ave
redwood city,  CA  94063
Original Contact nathaniel g butlin
Regulation Number862.3100
Classification Product Code
LCM  
Subsequent Product Codes
DIF   DKB  
Date Received09/04/2012
Decision Date 04/25/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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