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510(k) Data Aggregation

    K Number
    K072369
    Device Name
    EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    HMD BIOMEDICAL LLC
    Date Cleared
    2008-03-21

    (211 days)

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

    HMD BIOMEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Evolution™ Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in whole blood taken from the fingertip, ventral palm, dosal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. Evolution™ Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of diabetes or for neonatal use. Alternate site testing should be done during steady- state times when alucose is not changing rapidly.
    Device Description
    The Evolution™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the Evolution™ Test strip. The principle of the test replies upon a specific type of glucose in blood sample, the oxidase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generation an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood qlucose result.
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