17B ESTRADIOL

Radioimmunoassay, Estradiol

PANTEX, DIV. BIO-ANALYSIS, INC.

The following data is part of a premarket notification filed by Pantex, Div. Bio-analysis, Inc. with the FDA for 17b Estradiol.

Pre-market Notification Details

Device IDK810204
510k NumberK810204
Device Name:17B ESTRADIOL
ClassificationRadioimmunoassay, Estradiol
Applicant PANTEX, DIV. BIO-ANALYSIS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCHP  
CFR Regulation Number862.1260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-01-26
Decision Date1981-03-27

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