BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ARX Liquid Amies Collection & Transport System

    K Number: K222613 · Decision Mar 27, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    62
    Applicant Total
    2
    Review Days
    575

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    Basic Information

    Device Name
    ARX Liquid Amies Collection & Transport System
    K Number
    K222613
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arx Sciences, Inc.
    Date Received
    August 30, 2022
    Decision Date
    March 27, 2024
    Product Code
    LIO
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LIO Device, Specimen Collection

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