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510(k) Data Aggregation

    K Number
    K020210
    Device Name
    GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)
    Manufacturer
    BAYER GROUP DIAGNOSTICS
    Date Cleared
    2002-04-30

    (98 days)

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

    BAYER GROUP DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GLUCOMETER® DEX® 2 Blood Glucose Meter and the GLUCOMETER® DEX® Test Sensors are used to measure the glucose levels in whole blood from specimens taken from the fingers or an alternate puncture sites within cartain conditions. The GLUCOMETER® DEX® Diabetes Care System is an over-the-counter (OTC) device used by persons with diabetes in a home setting and by healthcare professionals in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
    Device Description
    The GLUCOMETER® DEX® Diabetes Care System includes: GLUCOMETER® DEX® 2 Blood Glucose Meter GLUCOMTER® DEX® Test Sensors This Diabetes Care System consists of an electrochemical methodbased meter and dry reagent sensor (test strips) designed for testing blood glucose by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
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    K Number
    K020208
    Device Name
    GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)
    Manufacturer
    BAYER GROUP DIAGNOSTICS
    Date Cleared
    2002-04-29

    (97 days)

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

    BAYER GROUP DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GLUCOMETER ELITE® and the GLUCOMETER ELITE® XL Blood Glucose Meters are used with GLUCOMETER ELITE® Test Strips to measure glucose levels in whole blood from specimens taken from the fingers or an alternate puncture site within certain conditions. The GLUCOMETER ELITE Diabetes Care System is an overthe-counter (OTC) device used by persons with diabetes in a home setting and by healthcare professionals in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
    Device Description
    The GLUCOMETER ELITE® Diabetes Care System includes the GLUCOMETER ELITE®, GLUCOMETER ELITE® XL Blood Glucose Meters and the GLUCOMETER ELITE® Test Strips. The system is an electrochemical method-based meter and dry reagent sensor (test strips) designed for testing blood glucose by persons with diabetes in the home or by healthcare professionals in healthcare facilities.
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