BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM

    K Number: K031898 · Decision Sep 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    38
    Applicant Total
    1
    Review Days
    97

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    Basic Information

    Device Name
    EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
    K Number
    K031898
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5620
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ekf Diagnostic GmbH
    Date Received
    June 19, 2003
    Decision Date
    September 24, 2003
    Product Code
    GKR
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GKR System, Hemoglobin, Automated

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