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

    Tacrolimus Assay Kit

    K Number: K203833 · Decision Jan 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    758

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    Basic Information

    Device Name
    Tacrolimus Assay Kit
    K Number
    K203833
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1678
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai Genext Medical Technology Co., Ltd.
    Date Received
    December 30, 2020
    Decision Date
    January 27, 2023
    Product Code
    MLM
    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
    MLM Enzyme Immunoassay, Tracrolimus

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