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

    TECHNICON RA-1000 SYS CO2

    K Number: K841080 · Decision May 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    157
    Review Days
    50

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    Basic Information

    Device Name
    TECHNICON RA-1000 SYS CO2
    K Number
    K841080
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Technicon Instruments Corp.
    Date Received
    March 13, 1984
    Decision Date
    May 2, 1984
    Product Code
    CHS
    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
    CHS Coulometric Method, Carbon-Dioxide

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