DPP Zika IgM System, DPP Zika IgM System Control Pack, And DPP Micro Reader

Zika Virus Serological Reagents

Chembio Diagnostic Systems

The following data is part of a premarket notification filed by Chembio Diagnostic Systems with the FDA for Dpp Zika Igm System, Dpp Zika Igm System Control Pack, And Dpp Micro Reader.

Pre-market Notification Details

Device IDK200506
510k NumberK200506
Device Name:DPP Zika IgM System, DPP Zika IgM System Control Pack, And DPP Micro Reader
ClassificationZika Virus Serological Reagents
Applicant Chembio Diagnostic Systems 3661 Horseblock Road Medford,  NY  11763
ContactLouise Muscat Sigismondi
CorrespondentLouise Muscat Sigismondi
Chembio Diagnostic Systems 3661 Horseblock Road Medford,  NY  11763
Product CodeQFO  
Subsequent Product CodeJJQ
Subsequent Product CodeQCH
CFR Regulation Number866.3935 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-02
Decision Date2020-06-03

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