RIA KIT, PROLACTIN

Radioimmunoassay, Prolactin (lactogen)

CIS RADIOPHARMACEUTICALS, INC.

The following data is part of a premarket notification filed by Cis Radiopharmaceuticals, Inc. with the FDA for Ria Kit, Prolactin.

Pre-market Notification Details

Device IDK790003
510k NumberK790003
Device Name:RIA KIT, PROLACTIN
ClassificationRadioimmunoassay, Prolactin (lactogen)
Applicant CIS RADIOPHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCFT  
CFR Regulation Number862.1625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-01-02
Decision Date1979-03-12

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