ENDAB T4 ENZYME IMMUNOASSAY KIT

Radioimmunoassay, Total Thyroxine

IMMUNOTECH CORP.

The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Endab T4 Enzyme Immunoassay Kit.

Pre-market Notification Details

Device IDK821141
510k NumberK821141
Device Name:ENDAB T4 ENZYME IMMUNOASSAY KIT
ClassificationRadioimmunoassay, Total Thyroxine
Applicant IMMUNOTECH CORP. 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 Received1982-04-21
Decision Date1982-05-13

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