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    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    UASure II Blood Uric Acid Monitoring System

    K Number: K242209 · Decision Apr 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    35
    Review Days
    249

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    Basic Information

    Device Name
    UASure II Blood Uric Acid Monitoring System
    K Number
    K242209
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apex BioTechnology Corp.
    Date Received
    July 29, 2024
    Decision Date
    April 4, 2025
    Product Code
    PTC
    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
    PTC Uric Acid Test System For At Home Prescription Use

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