The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel(tm) Anti-ds-dna Quantitative.
| Device ID | K902897 |
| 510k Number | K902897 |
| Device Name: | UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE |
| Classification | Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Applicant | UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View, CA 94043 |
| Contact | Annjoy Cheng |
| Correspondent | Annjoy Cheng UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View, CA 94043 |
| Product Code | LRM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-03 |
| Decision Date | 1990-07-16 |