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

    THE GOLDEN QUAD TEST (HSV)

    K Number: K861120 · Decision Feb 2, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    15
    Applicant Total
    14
    Review Days
    314

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    Basic Information

    Device Name
    THE GOLDEN QUAD TEST (HSV)
    K Number
    K861120
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microbiological Research Corp.
    Date Received
    March 25, 1986
    Decision Date
    February 2, 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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