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

    VIROGEN HERPES SLIDE TEST

    K Number: K852928 · Decision Oct 17, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    15
    Applicant Total
    68
    Review Days
    100

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    Basic Information

    Device Name
    VIROGEN HERPES SLIDE TEST
    K Number
    K852928
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Armkel, LLC
    Date Received
    July 9, 1985
    Decision Date
    October 17, 1985
    Product Code
    GQO
    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
    GQO Antisera, Cf, Herpesvirus Hominis 1,2

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