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 |