UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE

C-reactive Protein, Antigen, Antiserum, And Control

UNITED BIOTECH, INC.

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.

Pre-market Notification Details

Device IDK973692
510k NumberK973692
Device Name:UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE
ClassificationC-reactive Protein, Antigen, Antiserum, And Control
Applicant UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View,  CA  94041 -1517
ContactChin Shu Cheng
CorrespondentChin Shu Cheng
UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View,  CA  94041 -1517
Product CodeDCK  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-26
Decision Date1998-02-09

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