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 |