MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT

Radioimmunoassay, Thyroxine-binding Globulin

IMMUNOTECH CORP.

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

Pre-market Notification Details

Device IDK905777
510k NumberK905777
Device Name:MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT
ClassificationRadioimmunoassay, Thyroxine-binding Globulin
Applicant IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston,  MA  02134
ContactFrancis Capitanio
CorrespondentFrancis Capitanio
IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston,  MA  02134
Product CodeCEE  
CFR Regulation Number862.1685 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-27
Decision Date1991-01-30

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