EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT

Enzyme Immunoassay, Theophylline

IMMUNOTECH CORP.

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

Pre-market Notification Details

Device IDK881257
510k NumberK881257
Device Name:EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT
ClassificationEnzyme Immunoassay, Theophylline
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 CodeKLS  
CFR Regulation Number862.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-23
Decision Date1988-05-27

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