The following data is part of a premarket notification filed by Branan Medical Corp. with the FDA for Quicktox Multiple Drug Dipcard.
| Device ID | K023489 |
| 510k Number | K023489 |
| Device Name: | QUICKTOX MULTIPLE DRUG DIPCARD |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | BRANAN MEDICAL CORP. 10015 MUIRLANDS RD., SUITE E Irvine, CA 92618 |
| Contact | Chia Her |
| Correspondent | Chia Her 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 | LDZ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-17 |
| Decision Date | 2002-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816565021226 | K023489 | 000 |
| 00816555020949 | K023489 | 000 |