The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel Opiate Metabolites.
| Device ID | K973155 |
| 510k Number | K973155 |
| Device Name: | UBI MAGIWEL OPIATE METABOLITES |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View, CA 94041 -1517 |
| Contact | Wuan T Lu |
| Correspondent | Wuan T Lu UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View, CA 94041 -1517 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-22 |
| Decision Date | 1997-10-28 |