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

    DETERMINATION OF ANTITHROMBIN III, 885

    K Number: K790090 · Decision Feb 26, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    55
    Applicant Total
    231
    Review Days
    41

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    Basic Information

    Device Name
    DETERMINATION OF ANTITHROMBIN III, 885
    K Number
    K790090
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Sigma Chemical Co.
    Date Received
    January 16, 1979
    Decision Date
    February 26, 1979
    Product Code
    JBQ
    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
    JBQ Antithrombin Iii Quantitation

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