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

    i-STAT CG4+ cartridge with the i-STAT 1 System

    K Number: K244014 · Decision May 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    187
    Applicant Total
    20
    Review Days
    127

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    Basic Information

    Device Name
    i-STAT CG4+ cartridge with the i-STAT 1 System
    K Number
    K244014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1120
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Point of Care, Inc.
    Date Received
    December 26, 2024
    Decision Date
    May 2, 2025
    Product Code
    CHL
    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
    CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

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