The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel Pap (prostatic Acid Phosphatase) Eia Quantitatve.
| Device ID | K981573 |
| 510k Number | K981573 |
| Device Name: | UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE |
| Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
| 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 | JFH |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-04 |
| Decision Date | 1998-09-15 |