LUTEINIZING HORMONE

Radioimmunoassay, Luteinizing Hormone

PCL-RIA, INC.

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

Pre-market Notification Details

Device IDK810741
510k NumberK810741
Device Name:LUTEINIZING HORMONE
ClassificationRadioimmunoassay, Luteinizing Hormone
Applicant PCL-RIA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCEP  
CFR Regulation Number862.1485 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-19
Decision Date1981-03-31

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