UBI MAGIWEL RF-IGM QUANTITATIVE

System, Test, Rheumatoid Factor

UNITED BIOTECH, INC.

The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel Rf-igm Quantitative.

Pre-market Notification Details

Device IDK883355
510k NumberK883355
Device Name:UBI MAGIWEL RF-IGM QUANTITATIVE
ClassificationSystem, Test, Rheumatoid Factor
Applicant UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View,  CA  94043
ContactJoseph Fu
CorrespondentJoseph Fu
UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View,  CA  94043
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-09
Decision Date1988-09-07

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