MICRO DAU COCAINE METABOLITE TEST KIT

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

IMMUNOTECH CORP.

The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Micro Dau Cocaine Metabolite Test Kit.

Pre-market Notification Details

Device IDK896781
510k NumberK896781
Device Name:MICRO DAU COCAINE METABOLITE TEST KIT
ClassificationEnzyme Immunoassay, Cocaine And Cocaine Metabolites
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 CodeDIO  
CFR Regulation Number862.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-04
Decision Date1990-03-23

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