IMMUBEAD T4 ENZYME IMMUNOASSAY KIT

Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

IMMUNOTECH CORP.

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

Pre-market Notification Details

Device IDK872192
510k NumberK872192
Device Name:IMMUBEAD T4 ENZYME IMMUNOASSAY KIT
ClassificationEnzyme Immunoassay, Non-radiolabeled, Total Thyroxine
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 CodeKLI  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-08
Decision Date1987-08-13

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