QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61

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 Coc/met/thc/amp/pcp/bzo/bar/mtd/tca, Model Qt61.

Pre-market Notification Details

• Device ID: K022355
• 510k Number: K022355
• Device Name: QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
• Classification: Enzyme Immunoassay, Cocaine And Cocaine Metabolites
• Applicant: BRANAN MEDICAL CORP. 10015 MUIRLANDS RD., SUITE E Irvine, CA 92618
• Contact: Raphael Wong
• Correspondent: Raphael Wong; BRANAN MEDICAL CORP. 10015 MUIRLANDS RD., SUITE E Irvine, CA 92618
• Product Code: DIO
• Subsequent Product Code: DIS
• Subsequent Product Code: DJC
• Subsequent Product Code: DJG
• Subsequent Product Code: DJR
• Subsequent Product Code: DKZ
• Subsequent Product Code: JXM
• Subsequent Product Code: LCM
• Subsequent Product Code: LDJ
• Subsequent Product Code: LFH
• CFR Regulation Number: 862.3250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-07-19
• Decision Date: 2002-07-30

NIH GUDID Devices

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