THYROXINE T4 KIT

Radioimmunoassay, Total Thyroxine

PCL-RIA, INC.

The following data is part of a premarket notification filed by Pcl-ria, Inc. with the FDA for Thyroxine T4 Kit.

Pre-market Notification Details

Device IDK820886
510k NumberK820886
Device Name:THYROXINE T4 KIT
ClassificationRadioimmunoassay, Total Thyroxine
Applicant PCL-RIA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDX  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-03-30
Decision Date1982-04-16

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