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

    i-STAT TBI Cartridge with the i-STAT Alinity System

    K Number: K234143 · Decision Mar 27, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    89

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    Basic Information

    Device Name
    i-STAT TBI Cartridge with the i-STAT Alinity System
    K Number
    K234143
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5830
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Point of Care
    Date Received
    December 29, 2023
    Decision Date
    March 27, 2024
    Product Code
    QAT
    Advisory Committee
    Immunology
    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
    QAT Brain Trauma Assessment Test

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