The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel Cortisol Quantitative.
Device ID | K905473 |
510k Number | K905473 |
Device Name: | UBI MAGIWEL CORTISOL QUANTITATIVE |
Classification | Radioimmunoassay, Cortisol |
Applicant | UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View, CA 94043 |
Contact | Sun |
Correspondent | Sun UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View, CA 94043 |
Product Code | CGR |
CFR Regulation Number | 862.1205 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-06 |
Decision Date | 1991-01-31 |