The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel Cmv Igg Quantitative.
| Device ID | K883399 |
| 510k Number | K883399 |
| Device Name: | UBI MAGIWEL CMV IGG QUANTITATIVE |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| 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 | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-11 |
| Decision Date | 1989-03-27 |