ESTRIOL-SQUIBB RIA KIT

Radioimmunoassay, Estriol

E. R. SQUIBB & SONS, INC.

The following data is part of a premarket notification filed by E. R. Squibb & Sons, Inc. with the FDA for Estriol-squibb Ria Kit.

Pre-market Notification Details

Device IDK802455
510k NumberK802455
Device Name:ESTRIOL-SQUIBB RIA KIT
ClassificationRadioimmunoassay, Estriol
Applicant E. R. SQUIBB & SONS, INC. 40 W 57TH ST. New York,  NY  10019
Product CodeCGI  
CFR Regulation Number862.1265 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-08
Decision Date1980-10-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.