QUICKTOX MULTIPLE DRUG DIPCARD

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

BRANAN MEDICAL CORP.

The following data is part of a premarket notification filed by Branan Medical Corp. with the FDA for Quicktox Multiple Drug Dipcard.

Pre-market Notification Details

Device IDK023489
510k NumberK023489
Device Name:QUICKTOX MULTIPLE DRUG DIPCARD
ClassificationEnzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant BRANAN MEDICAL CORP. 10015 MUIRLANDS RD., SUITE E Irvine,  CA  92618
ContactChia Her
CorrespondentChia Her
BRANAN MEDICAL CORP. 10015 MUIRLANDS RD., SUITE E Irvine,  CA  92618
Product CodeDIO  
Subsequent Product CodeDIS
Subsequent Product CodeDJC
Subsequent Product CodeDJG
Subsequent Product CodeDJR
Subsequent Product CodeDKZ
Subsequent Product CodeJXM
Subsequent Product CodeLCM
Subsequent Product CodeLDJ
Subsequent Product CodeLDZ
Subsequent Product CodeLFG
CFR Regulation Number862.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-17
Decision Date2002-12-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816565021226 K023489 000
00816555020949 K023489 000

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