FOLLICLE STIMULATING HORMONE KIT

Radioimmunoassay, Follicle-stimulating Hormone

PCL-RIA, INC.

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

Pre-market Notification Details

Device IDK820358
510k NumberK820358
Device Name:FOLLICLE STIMULATING HORMONE KIT
ClassificationRadioimmunoassay, Follicle-stimulating Hormone
Applicant PCL-RIA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGJ  
CFR Regulation Number862.1300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-02-09
Decision Date1982-03-26

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