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.
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 |