BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

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

    K Number: K200506 · Decision Jun 3, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    93

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    Basic Information

    Device Name
    DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
    K Number
    K200506
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3935
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chembio Diagnostic Systems
    Date Received
    March 2, 2020
    Decision Date
    June 3, 2020
    Product Code
    QFO
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QFO Zika Virus Serological Reagents

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