The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel Ferritin Quantitative.
Device ID | K951993 |
510k Number | K951993 |
Device Name: | UBI MAGIWEL FERRITIN QUANTITATIVE |
Classification | Ferritin, Antigen, Antiserum, Control |
Applicant | UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View, CA 94041 -1517 |
Contact | Sharon Sun |
Correspondent | Sharon Sun UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View, CA 94041 -1517 |
Product Code | DBF |
CFR Regulation Number | 866.5340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-28 |
Decision Date | 1995-07-05 |