The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel(tm) Ana Quantitative.
| Device ID | K910033 |
| 510k Number | K910033 |
| Device Name: | UBI MAGIWEL(TM) ANA QUANTITATIVE |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| 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 | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-04 |
| Decision Date | 1991-01-25 |