UBI MAGIWEL CMV IGG QUANTITATIVE

Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

UNITED BIOTECH, INC.

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

Pre-market Notification Details

Device IDK883399
510k NumberK883399
Device Name:UBI MAGIWEL CMV IGG QUANTITATIVE
ClassificationEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
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 CodeLFZ  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-11
Decision Date1989-03-27

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