BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    STA® - Liatest® D-Di

    K Number: K162227 · Decision Dec 10, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    56
    Applicant Total
    2
    Review Days
    124

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    Basic Information

    Device Name
    STA® - Liatest® D-Di
    K Number
    K162227
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7320
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostica Stago
    Date Received
    August 8, 2016
    Decision Date
    December 10, 2016
    Product Code
    DAP
    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
    DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

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