THYROXINE STDS. IN HUMAN SERUM

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 Stds. In Human Serum.

Pre-market Notification Details

Device IDK780050
510k NumberK780050
Device Name:THYROXINE STDS. IN HUMAN SERUM
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 Received1978-01-09
Decision Date1978-02-13

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