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

    TOTAL CO2 REAGENT SET

    K Number: K832071 · Decision Aug 11, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    56
    Review Days
    45

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    Basic Information

    Device Name
    TOTAL CO2 REAGENT SET
    K Number
    K832071
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    American Research Products Co.
    Date Received
    June 27, 1983
    Decision Date
    August 11, 1983
    Product Code
    CIE
    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
    CIE Volumetric/Manometric, Carbon-Dioxide

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