RIA KIT, GAMMACOAT

Radioimmunoassay, Total Thyroxine

CLINICAL ASSAYS, INC.

The following data is part of a premarket notification filed by Clinical Assays, Inc. with the FDA for Ria Kit, Gammacoat.

Pre-market Notification Details

Device IDK782109
510k NumberK782109
Device Name:RIA KIT, GAMMACOAT
ClassificationRadioimmunoassay, Total Thyroxine
Applicant CLINICAL ASSAYS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCDX  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-12-19
Decision Date1979-01-26

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