I-ESTRIOL TEST SET

Radioimmunoassay, Estriol

WIEN LABORATORIES, INC.

The following data is part of a premarket notification filed by Wien Laboratories, Inc. with the FDA for I-estriol Test Set.

Pre-market Notification Details

Device IDK781599
510k NumberK781599
Device Name:I-ESTRIOL TEST SET
ClassificationRadioimmunoassay, Estriol
Applicant WIEN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGI  
CFR Regulation Number862.1265 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-09-18
Decision Date1978-10-17

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