125 I-T4 RIA TEST KIT

Radioimmunoassay, Total Thyroxine

INTL. IMMUNOASSAY LABORATORIES, INC.

The following data is part of a premarket notification filed by Intl. Immunoassay Laboratories, Inc. with the FDA for 125 I-t4 Ria Test Kit.

Pre-market Notification Details

Device IDK811070
510k NumberK811070
Device Name:125 I-T4 RIA TEST KIT
ClassificationRadioimmunoassay, Total Thyroxine
Applicant INTL. IMMUNOASSAY LABORATORIES, 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 Received1981-04-20
Decision Date1981-04-29

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