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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    MAGLUMI 2000 FT4

    K Number: K182423 · Decision Oct 4, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    91
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    MAGLUMI 2000 FT4
    K Number
    K182423
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1695
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen New Industries Biomedical Engineering Co., Ltd.
    Date Received
    September 6, 2018
    Decision Date
    October 4, 2018
    Product Code
    CEC
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CEC Radioimmunoassay, Free Thyroxine

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