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 |