LUTEINIZING HORMONE (LH) RIA

Radioimmunoassay, Luteinizing Hormone

CIS RADIOPHARMACEUTICALS, INC.

The following data is part of a premarket notification filed by Cis Radiopharmaceuticals, Inc. with the FDA for Luteinizing Hormone (lh) Ria.

Pre-market Notification Details

Device IDK792000
510k NumberK792000
Device Name:LUTEINIZING HORMONE (LH) RIA
ClassificationRadioimmunoassay, Luteinizing Hormone
Applicant CIS RADIOPHARMACEUTICALS, 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 Received1979-10-05
Decision Date1979-10-30

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