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

    MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

    K Number: K162698 · Decision Jul 14, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    241
    Applicant Total
    5
    Review Days
    290

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    Basic Information

    Device Name
    MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
    K Number
    K162698
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen New Industries Biomedical Engineering Co., Ltd.
    Date Received
    September 27, 2016
    Decision Date
    July 14, 2017
    Product Code
    JLW
    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
    JLW Radioimmunoassay, Thyroid-Stimulating Hormone

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    Other Clearances by Shenzhen New Industries Biomedical Engineering Co., Ltd.

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