EZ-BEAD DIGOXIN EIA KIT

Enzyme Immunoassay, Digoxin

IMMUNOTECH CORP.

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

Pre-market Notification Details

Device IDK893843
510k NumberK893843
Device Name:EZ-BEAD DIGOXIN EIA KIT
ClassificationEnzyme Immunoassay, Digoxin
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 CodeKXT  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-25
Decision Date1989-09-28

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