UBI MAGIWEL CORTISOL QUANTITATIVE

Radioimmunoassay, Cortisol

UNITED BIOTECH, INC.

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

Pre-market Notification Details

Device IDK905473
510k NumberK905473
Device Name:UBI MAGIWEL CORTISOL QUANTITATIVE
ClassificationRadioimmunoassay, Cortisol
Applicant UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View,  CA  94043
ContactSun
CorrespondentSun
UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View,  CA  94043
Product CodeCGR  
CFR Regulation Number862.1205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-06
Decision Date1991-01-31

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