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 |