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

    VARICELLA-ZOSTER FA LABELED PRESERUM

    K Number: K770810 · Decision May 20, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    57
    Review Days
    17

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    Basic Information

    Device Name
    VARICELLA-ZOSTER FA LABELED PRESERUM
    K Number
    K770810
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Flow Laboratories, Inc.
    Date Received
    May 3, 1977
    Decision Date
    May 20, 1977
    Product Code
    GQX
    Advisory Committee
    Microbiology
    Review Advisory Committee
    IM
    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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