The following data is part of a premarket notification filed by Branan Medical Corporation with the FDA for Branan Medical Corporation Monitect Bzo Drug Screen Test.
| Device ID | K002342 |
| 510k Number | K002342 |
| Device Name: | BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | BRANAN MEDICAL CORPORATION 10015 MUIRLANDS RD. SUITE E Irvine, CA 92618 |
| Contact | Raphael Wong |
| Correspondent | Raphael Wong BRANAN MEDICAL CORPORATION 10015 MUIRLANDS RD. SUITE E Irvine, CA 92618 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-01 |
| Decision Date | 2000-11-27 |