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510(k) Data Aggregation

    K Number
    K072905
    Device Name
    3TEST SUPREME GLUCOSE MONITORING SYSTEM
    Date Cleared
    2008-04-18

    (190 days)

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

    NEUERO ENGINEERING INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 3test® Glucose Supreme Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.
    Device Description
    Based on an electrochemical biosensor technology and the principle of capillary action, 3test* Supreme Glucose Monitoring System only needs a small amount of blood ( 2μL. same as predicate device ). Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 5 seconds, and 200 blood glucose result memory.
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    K Number
    K050224
    Device Name
    3TEST GLUCOSE MONITORING SYSTEM
    Date Cleared
    2005-07-13

    (163 days)

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

    NEUERO ENGINEERING INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 3test® Glucose test strip is intended to measure the glucose in whole blood with the 3test® Glucose Monitoring System. It is suitable for a person with diabetes to monitor their blood glucose at home by themselves. The 3test® Glucose Monitoring System can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood. NOTE: a. the 3test is to be used with capillary whole blood from the fingertip b. the 3test is not for use with neonates b. the stest meter is to be used with the 3test Blood Glucose Test Strip, and the 3test High and Low Glucose Control Solutions
    Device Description
    Based on an electrochemical biosensor technology and the principle of capillary action, 3test® Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and is displayed in 5 seconds, and 100 blood glucose result memory.
    Ask a Question

    Ask a specific question about this device

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