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

    GLB VARICELLA-ZOSTER VIRUS FLUORESCENT

    K Number: K842096 · Decision Jan 7, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    227

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    Basic Information

    Device Name
    GLB VARICELLA-ZOSTER VIRUS FLUORESCENT
    K Number
    K842096
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Great Lakes Bioscience
    Date Received
    May 25, 1984
    Decision Date
    January 7, 1985
    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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