The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel(tm) Fsh Quantitative.
| Device ID | K864080 |
| 510k Number | K864080 |
| Device Name: | UBI MAGIWEL(TM) FSH QUANTITATIVE |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View, CA 94043 |
| Contact | Joseph Fu |
| Correspondent | Joseph Fu UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View, CA 94043 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-20 |
| Decision Date | 1986-11-13 |