The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel Amphetamine Metabolites.
Device ID | K973153 |
510k Number | K973153 |
Device Name: | UBI MAGIWEL AMPHETAMINE 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 |