UBI MAGIWEL FERRITIN QUANTITATIVE

Ferritin, Antigen, Antiserum, Control

UNITED BIOTECH, INC.

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

Pre-market Notification Details

Device IDK951993
510k NumberK951993
Device Name:UBI MAGIWEL FERRITIN QUANTITATIVE
ClassificationFerritin, Antigen, Antiserum, Control
Applicant UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View,  CA  94041 -1517
ContactSharon Sun
CorrespondentSharon Sun
UNITED BIOTECH, INC. 110 PIONEER WAY, #C Mountain View,  CA  94041 -1517
Product CodeDBF  
CFR Regulation Number866.5340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-28
Decision Date1995-07-05

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