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    K Number
    K152442
    Device Name
    Freestyle Freedom Blood Glucose Monitoring Sytem
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    2015-12-17

    (112 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FreeStyle Freedom Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program by quantitatively measuring glucose in fresh whole blood from the finger, upper arm and palm. The FreeStyle Freedom Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. It is intended to be used by a single person and should not be shared. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly). The FreeStyle Blood Glucose Test Strips are for use with the FreeStyle Freedom Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, upper arm and palm.

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