BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EBV TEST

    K Number: K771062 · Decision Jul 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    19
    Applicant Total
    57
    Review Days
    31

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    Basic Information

    Device Name
    EBV TEST
    K Number
    K771062
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Gull Laboratories, Inc.
    Date Received
    June 13, 1977
    Decision Date
    July 14, 1977
    Product Code
    GNP
    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
    GNP Antiserum, Cf, Epstein-Barr Virus

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