The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel C-reactive Protein(crp) Quantitative.
| Device ID | K973692 |
| 510k Number | K973692 |
| Device Name: | UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View, CA 94041 -1517 |
| Contact | Chin Shu Cheng |
| Correspondent | Chin Shu Cheng UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View, CA 94041 -1517 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-26 |
| Decision Date | 1998-02-09 |