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

    LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG

    K Number: K081687 · Decision Nov 10, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    9
    Applicant Total
    71
    Review Days
    146

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    Basic Information

    Device Name
    LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
    K Number
    K081687
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DiaSorin, Inc.
    Date Received
    June 17, 2008
    Decision Date
    November 10, 2008
    Product Code
    MYF
    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
    MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

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