The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel Rf-igm Quantitative.
Device ID | K883355 |
510k Number | K883355 |
Device Name: | UBI MAGIWEL RF-IGM QUANTITATIVE |
Classification | System, Test, Rheumatoid Factor |
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 | DHR |
CFR Regulation Number | 866.5775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-09 |
Decision Date | 1988-09-07 |