K200506

Substantially Equivalent

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

Applicant: Chembio Diagnostic Systems
Product code: QFO
Advisory panel: Microbiology
Date received: 2020-03-02
Decision date: 2020-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medford, NY, US

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