The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Hcg-magiwell Eia Early Pregnancy Test.
| Device ID | K851076 |
| 510k Number | K851076 |
| Device Name: | UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View, CA 94043 |
| Contact | Wuan Lu |
| Correspondent | Wuan Lu UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View, CA 94043 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-18 |
| Decision Date | 1985-05-10 |