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

    ENZYGNOST ANTI-VZV IGG TEST

    K Number: K863317 · Decision Apr 22, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    145
    Review Days
    239

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    Basic Information

    Device Name
    ENZYGNOST ANTI-VZV IGG TEST
    K Number
    K863317
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Behring Diagnostics, Inc.
    Date Received
    August 26, 1986
    Decision Date
    April 22, 1987
    Product Code
    GQX
    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
    GQX Antiserum, Cf, Varicella-Zoster

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