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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
Device Name TOXCUP DRUG SCREEN CUP
Applicant
BRANAN MEDICAL CORP.
140 Technology Dr Ste 400
IRVINE,  CA  92618
Applicant Contact Olivia Chan
Correspondent
BRANAN MEDICAL CORP.
140 Technology Dr Ste 400
IRVINE,  CA  92618
Correspondent 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 (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
Recalls CDRH Recalls
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