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510(k) Data Aggregation

    K Number
    K070239
    Device Name
    MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM
    Date Cleared
    2007-05-25

    (120 days)

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

    EXIR PHARMACEUTICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Maximed Exichek TD 4224 Blood glucose monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in the Maximed Exichek TD 4224 Blood glucose monitoring system can be used only during steady-state blood glucose conditions.
    Device Description
    Maximed Exichek TD 4224 blood glucose monitoring system consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
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