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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 K022355
Device Name QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
Applicant
BRANAN MEDICAL CORP.
10015 MUIRLANDS RD., SUITE E
IRVINE,  CA  92618
Applicant Contact RAPHAEL WONG
Correspondent
BRANAN MEDICAL CORP.
10015 MUIRLANDS RD., SUITE E
IRVINE,  CA  92618
Correspondent Contact RAPHAEL WONG
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DIS   DJC   DJG   DJR   DKZ  
JXM   LCM   LDJ   LFH  
Date Received07/19/2002
Decision Date 07/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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