The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel(tm) Prolactin Quantative.
| Device ID | K864075 |
| 510k Number | K864075 |
| Device Name: | UBI MAGIWEL(TM) PROLACTIN QUANTATIVE |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| 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 | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-20 |
| Decision Date | 1986-12-16 |