BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    EXTENDSURE HBFASC CONTROL

    K Number: K053031 · Decision Dec 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    41

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    Basic Information

    Device Name
    EXTENDSURE HBFASC CONTROL
    K Number
    K053031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7415
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cantebury Scientific , Ltd.
    Date Received
    October 27, 2005
    Decision Date
    December 7, 2005
    Product Code
    JCM
    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
    JCM Control, Hemoglobin, Abnormal

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