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

    HERPES EIA TEST KIT

    K Number: K791397 · Decision Sep 24, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    8
    Review Days
    59

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    Basic Information

    Device Name
    HERPES EIA TEST KIT
    K Number
    K791397
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microbiological Assoc.
    Date Received
    July 27, 1979
    Decision Date
    September 24, 1979
    Product Code
    GQM
    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
    GQM Antisera, Neutralization, Herpesvirus Hominis

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