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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
Recalls CDRH Recalls
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