UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE

Radioimmunoassay, Total Triiodothyronine

UNITED BIOTECH, INC.

The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel Triiodothyronine(t3) Quantitative.

Pre-market Notification Details

Device IDK961236
510k NumberK961236
Device Name:UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE
ClassificationRadioimmunoassay, Total Triiodothyronine
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 CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-29
Decision Date1996-05-30

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