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510(k) Data Aggregation

    K Number
    K061234
    Device Name
    GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    Date Cleared
    2006-10-30

    (181 days)

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

    GLUCOPLUS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Glucoplus™ Blood Glucose Test System is comprised of Control Solutions and Test Strip biosensors for use only with the Glucoplus™ Blood Glucose Meter. It is for quantitative measurement of the concentration of glucose in capillary whole blood taken from the fingerstick by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
    Device Description
    GlucoPlus™ Blood Glucose Monitoring System is comprised of an electrchemical biosensor glucose reagent test strip, a hand held meter, quality control solutions, a user manual, a check strip, a lancet, lancets and a logbook for recording test results. When the user inserts a test strip , the meter turns on. The user acquires a blood sample by touching the aperture of the test strip to the finger tip blood drop to fill the chamber on the strip. The meter sounds a beep to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its LCD.
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