The following data is part of a premarket notification filed by Branan Medical Corporation with the FDA for Branan Medical Corporation Monitect Methadone Drug Screen Test, Model 190c And 190d.
| Device ID | K002417 |
| 510k Number | K002417 |
| Device Name: | BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D |
| Classification | Enzyme Immunoassay, Methadone |
| 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 | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-08 |
| Decision Date | 2000-11-22 |