FOLLICLE STIMULATING HORMONE (FSH) KIT

Radioimmunoassay, Follicle-stimulating Hormone

CIS RADIOPHARMACEUTICALS, INC.

The following data is part of a premarket notification filed by Cis Radiopharmaceuticals, Inc. with the FDA for Follicle Stimulating Hormone (fsh) Kit.

Pre-market Notification Details

Device IDK792063
510k NumberK792063
Device Name:FOLLICLE STIMULATING HORMONE (FSH) KIT
ClassificationRadioimmunoassay, Follicle-stimulating Hormone
Applicant CIS RADIOPHARMACEUTICALS, 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 Received1979-10-15
Decision Date1979-11-20

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