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

    THREE LEVEL CONTROL SERA

    K Number: K810459 · Decision Aug 3, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    27
    Applicant Total
    632
    Review Days
    164

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    Basic Information

    Device Name
    THREE LEVEL CONTROL SERA
    K Number
    K810459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    February 20, 1981
    Decision Date
    August 3, 1981
    Product Code
    DHX
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DHX System, Test, Carcinoembryonic Antigen

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