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

    Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

    K Number: K231137 · Decision May 19, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
    K Number
    K231137
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xenta Biomedical Science Co., Ltd.
    Date Received
    April 21, 2023
    Decision Date
    May 19, 2023
    Product Code
    DKZ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DKZ Enzyme Immunoassay, Amphetamine

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    Other Clearances by Xenta Biomedical Science Co., Ltd.

    K Number Device Name
    K222955 Xenta Drug Screen Cup, Xenta Drug Screen Dipcard