ENDAB T3

Radioimmunoassay, Total Triiodothyronine

IMMUNOTECH CORP.

The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Endab T3.

Pre-market Notification Details

Device IDK834049
510k NumberK834049
Device Name:ENDAB T3
ClassificationRadioimmunoassay, Total Triiodothyronine
Applicant IMMUNOTECH CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-23
Decision Date1984-01-30

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