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

    ANTITHROMBIN III RIA

    K Number: K780012 · Decision Jan 20, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    7
    Review Days
    17

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    Basic Information

    Device Name
    ANTITHROMBIN III RIA
    K Number
    K780012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Ria Diagnostics
    Date Received
    January 3, 1978
    Decision Date
    January 20, 1978
    Product Code
    DDQ
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DDQ Antigen, Antiserum, Control, Antithrombin Iii

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