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

    DIASORIN LIAISON VZV IGG

    K Number: K061820 · Decision Feb 26, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    71
    Review Days
    243

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    Basic Information

    Device Name
    DIASORIN LIAISON VZV IGG
    K Number
    K061820
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DiaSorin, Inc.
    Date Received
    June 28, 2006
    Decision Date
    February 26, 2007
    Product Code
    LFY
    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
    LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster

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