BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    AUTION EYE AI-4510 Urine Particle Analysis System

    K Number: K232416 · Decision May 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    14
    Applicant Total
    18
    Review Days
    266

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    Basic Information

    Device Name
    AUTION EYE AI-4510 Urine Particle Analysis System
    K Number
    K232416
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arkray, Inc.
    Date Received
    August 11, 2023
    Decision Date
    May 3, 2024
    Product Code
    LKM
    Advisory Committee
    Hematology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKM Counter, Urine Particle

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