EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT

Enzyme Immunoassay, Diphenylhydantoin

IMMUNOTECH CORP.

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

Pre-market Notification Details

Device IDK901080
510k NumberK901080
Device Name:EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT
ClassificationEnzyme Immunoassay, Diphenylhydantoin
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 CodeDIP  
CFR Regulation Number862.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-07
Decision Date1990-05-17

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