STANDARDS, HORMONE, THYROID STIMULATING

Calibrator, Secondary

PCL-RIA, INC.

The following data is part of a premarket notification filed by Pcl-ria, Inc. with the FDA for Standards, Hormone, Thyroid Stimulating.

Pre-market Notification Details

Device IDK781071
510k NumberK781071
Device Name:STANDARDS, HORMONE, THYROID STIMULATING
ClassificationCalibrator, Secondary
Applicant PCL-RIA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-06-26
Decision Date1978-08-14

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