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

    LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set

    K Number: K192046 · Decision Oct 28, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    3
    Applicant Total
    71
    Review Days
    89

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    Basic Information

    Device Name
    LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
    K Number
    K192046
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3935
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DiaSorin, Inc.
    Date Received
    July 31, 2019
    Decision Date
    October 28, 2019
    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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