The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel(tm) Helicobacter Pylori Igg.
| Device ID | K924689 |
| 510k Number | K924689 |
| Device Name: | UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG |
| Classification | Helicobacter Pylori |
| Applicant | UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View, CA 94041 -1517 |
| Contact | Joseph Fu |
| Correspondent | Joseph Fu UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View, CA 94041 -1517 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-17 |
| Decision Date | 1993-08-10 |