BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    KidneyIntelX.dkd

    K Number: DEN200052 · Decision Jun 29, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    1037

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    Basic Information

    Device Name
    KidneyIntelX.dkd
    K Number
    DEN200052
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    862.1223
    Medical Specialty
    Clinical Chemistry
    Decision
    Unknown
    Applicant
    Renalytix Ai, Inc.
    Date Received
    August 26, 2020
    Decision Date
    June 29, 2023
    Product Code
    QWZ
    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
    QWZ Prognostic Test For Assessment Of Chronic Kidney Disease Progression