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510(k) Data Aggregation

    K Number
    K052207
    Device Name
    ACCUREX GLUCOSE TEST STRIP
    Manufacturer
    INCLINE MEDICAL, LLC
    Date Cleared
    2006-03-09

    (209 days)

    Product Code
    CGANBW
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    INCLINE MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Accurex Glucose Test Strip for use with the following glucometers: One Touchi Basic, OneTouch II and OneTouch Profile meters, all manufactured by Lifescan, Inc. It is to be used for the quantitative measurement of glucose in fresh capillary whole blood. Glucose measurements are used as an aid to monitor the effectiveness of diabetes control.
    Device Description
    The Accurex Glucose Test Strip is a generic replacement for the Lifescan One Touch Glucose Test Strip. These glucose test strips can be used with the following glucometers: One Touch Profile, One Touch II, One Touch Basic (with large screen), One Touch Basic (with small screen).
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