MICROZYME 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 Microzyme T3 Enzyme Immunoassay Kit.

Pre-market Notification Details

Device IDK904820
510k NumberK904820
Device Name:MICROZYME T3 ENZYME IMMUNOASSAY KIT
ClassificationRadioimmunoassay, Total Triiodothyronine
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 CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-24
Decision Date1990-12-18

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