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510(k) Data Aggregation

    K Number
    K031898
    Device Name
    EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
    Manufacturer
    EKF DIAGNOSTIC GMBH
    Date Cleared
    2003-09-24

    (97 days)

    Product Code
    GKR, KHG
    Regulation Number
    864.5620
    Why did this record match?
    Applicant Name (Manufacturer) :

    EKF DIAGNOSTIC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemo Control Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood. The microcuvettes part number 3000-3011-050 are indicated for use in the Hemo Control Hemoglobin Measurement System and compatible measurement systems. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste. Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter ). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported. For In Vitro Diagnostic Use Only Caution: Federal law restricts this device to sale by or on the order of a physician.
    Device Description
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