BEUDAMED
    Product Code: CIE FDA class 2 21 CFR 862.1160

    Volumetric/Manometric, Carbon-Dioxide

    Clinical Chemistry

    The Volumetric/Manometric, Carbon Dioxide test system (product code CIE) is an in-vitro diagnostic device used in clinical chemistry to measure total carbon dioxide or bicarbonate in biological specimens using volumetric or manometric physical measurement techniques, supporting acid-base evaluation. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1160 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    View on FDA
    510(k)s
    7
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    6
    Years Active
    13

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    Basic Information

    Product Code
    CIE
    Device Class
    FDA class 2
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K904761 P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT
    K880967 MICRO CO2 APPARATUS
    K864313 CO2 REAGENT SET
    K832071 TOTAL CO2 REAGENT SET
    K820091 AIRMED SMOKE EVACUATION & FILTER
    K800524 SERALYZER REFLECTANCE PHOTOMETER/CALIB.
    K771610 CARBON DIOXIDE ANALYZER