The following data is part of a premarket notification filed by Branan Medical Corporation with the FDA for Branan Medical Corporation Monitect Morphine 300 Drug Screen Test, Model 133c And 133d.
| Device ID | K002418 |
| 510k Number | K002418 |
| Device Name: | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D |
| Classification | Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. |
| 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 | DOE |
| CFR Regulation Number | 862.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-08 |
| Decision Date | 2000-11-22 |