FOLLICLE STIMULATING HORMONE DIRECT RIA

Radioimmunoassay, Follicle-stimulating Hormone

Immunalysis Corporation

The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Follicle Stimulating Hormone Direct Ria.

Pre-market Notification Details

Device IDK811905
510k NumberK811905
Device Name:FOLLICLE STIMULATING HORMONE DIRECT RIA
ClassificationRadioimmunoassay, Follicle-stimulating Hormone
Applicant Immunalysis Corporation 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 Received1981-07-01
Decision Date1981-07-23

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