Pointe Scientific Cocaine Metabolite Enzyme Immunoassay

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

MedTest Dx

The following data is part of a premarket notification filed by Medtest Dx with the FDA for Pointe Scientific Cocaine Metabolite Enzyme Immunoassay.

Pre-market Notification Details

Device IDK191638
510k NumberK191638
Device Name:Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
ClassificationEnzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant MedTest Dx 5449 Research Drive Canton,  MI  48188
ContactWilliam Cripps
CorrespondentWilliam Cripps
MedTest Dx 5449 Research Drive Canton,  MI  48188
Product CodeDIO  
CFR Regulation Number862.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyToxicology
510k Review PanelToxicology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-19
Decision Date2020-03-12

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