IMMUBEAD T3 ENZYME IMMUNOASSAY KIT

Radioimmunoassay, Total Triiodothyronine

IMMUNOTECH CORP.

The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Immubead T3 Enzyme Immunoassay Kit.

Pre-market Notification Details

Device IDK872191
510k NumberK872191
Device Name:IMMUBEAD T3 ENZYME IMMUNOASSAY KIT
ClassificationRadioimmunoassay, Total Triiodothyronine
Applicant IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston,  MA  02134
ContactE Capitanio
CorrespondentE Capitanio
IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston,  MA  02134
Product CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-08
Decision Date1987-08-13

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