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

    HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)

    K Number: K011389 · Decision Jun 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    45

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    Basic Information

    Device Name
    HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
    K Number
    K011389
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7415
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Canterbury Health Laboratories
    Date Received
    May 7, 2001
    Decision Date
    June 21, 2001
    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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