The following data is part of a premarket notification filed by Branan Medical Corp. with the FDA for Toxcup Drug Screen Cup Amp/coc/met/opi/pcp/thc.
| Device ID | K032057 |
| 510k Number | K032057 |
| Device Name: | TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC |
| 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 | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-02 |
| Decision Date | 2003-08-21 |