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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, cannabinoids
510(k) Number K122633
Model DT14, DT14S
Device Name TOXCUP DRUG SCREEN CUP
Original Applicant
BRANAN MEDICAL CORP.
140 technology dr ste 400
irvine,  CA  92618
Original Contact olivia chan
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
DKZ   JXM   JXN   LCM   LFG  
Date Received08/29/2012
Decision Date 02/07/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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