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

    MAGLUMI 2000 HCG/ß-HCG

    K Number: K192547 · Decision Jan 17, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    71
    Applicant Total
    5
    Review Days
    122

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    Basic Information

    Device Name
    MAGLUMI 2000 HCG/ß-HCG
    K Number
    K192547
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen New Industries Biomedical Engineering Co., Ltd.
    Date Received
    September 17, 2019
    Decision Date
    January 17, 2020
    Product Code
    DHA
    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
    DHA System, Test, Human Chorionic Gonadotropin

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

    K Number Device Name
    K232587 MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
    K191499 MAGLUMI 2000 25-OH Vitamin D
    K182423 MAGLUMI 2000 FT4
    K162698 MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer