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

    VIROGEN HSV ANTIBODY TEST

    K Number: K871426 · Decision Oct 15, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    15
    Applicant Total
    68
    Review Days
    189

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    Basic Information

    Device Name
    VIROGEN HSV ANTIBODY TEST
    K Number
    K871426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Armkel, LLC
    Date Received
    April 9, 1987
    Decision Date
    October 15, 1987
    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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