FOLLICLE STIMULATING HORMONE ANTISERUM

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 Antiserum.

Pre-market Notification Details

Device IDK810852
510k NumberK810852
Device Name:FOLLICLE STIMULATING HORMONE ANTISERUM
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 Received1981-03-30
Decision Date1981-04-08

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