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

    THROMBONOSTIKA F1.2

    K Number: K964934 · Decision Mar 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    130
    Review Days
    99

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    Basic Information

    Device Name
    THROMBONOSTIKA F1.2
    K Number
    K964934
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7320
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Organon Teknika Corp.
    Date Received
    December 9, 1996
    Decision Date
    March 18, 1997
    Product Code
    MIF
    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
    MIF Prothrombin Fragment 1.2

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