EZ-BEAD TSH ENZYME IMMUNOASSAY KIT

Radioimmunoassay, Thyroid-stimulating Hormone

IMMUNOTECH CORP.

The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Ez-bead Tsh Enzyme Immunoassay Kit.

Pre-market Notification Details

Device IDK903725
510k NumberK903725
Device Name:EZ-BEAD TSH ENZYME IMMUNOASSAY KIT
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston,  MA  02134
ContactFrancis E Capitanio
CorrespondentFrancis E Capitanio
IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston,  MA  02134
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-16
Decision Date1990-10-26

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