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

    AGGLUTINOTEST-SYPHILIS

    K Number: K791457 · Decision Sep 24, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    66
    Review Days
    49

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    Basic Information

    Device Name
    AGGLUTINOTEST-SYPHILIS
    K Number
    K791457
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Volu Sol Medical Industries
    Date Received
    August 6, 1979
    Decision Date
    September 24, 1979
    Product Code
    GMT
    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
    GMT Antigens, Ha, Treponema Pallidum

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