HUMAN FOLLICLE STIMULATING HORMONE

Radioimmunoassay, Estriol

PCL-RIA, INC.

The following data is part of a premarket notification filed by Pcl-ria, Inc. with the FDA for Human Follicle Stimulating Hormone.

Pre-market Notification Details

Device IDK780016
510k NumberK780016
Device Name:HUMAN FOLLICLE STIMULATING HORMONE
ClassificationRadioimmunoassay, Estriol
Applicant PCL-RIA, 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 Received1978-01-03
Decision Date1978-02-03

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