UBI MAGIWEL THYROXINE (T4) QUANTITATIVE

Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

UNITED BIOTECH, INC.

The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel Thyroxine (t4) Quantitative.

Pre-market Notification Details

Device IDK962211
510k NumberK962211
Device Name:UBI MAGIWEL THYROXINE (T4) QUANTITATIVE
ClassificationEnzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Applicant UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View,  CA  94041 -1517
ContactWuan T Lu
CorrespondentWuan T Lu
UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View,  CA  94041 -1517
Product CodeKLI  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-10
Decision Date1996-07-08

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