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

    CALIBRATORS, CARBON DIOXIDE

    K Number: K780295 · Decision Apr 5, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    244
    Applicant Total
    253
    Review Days
    43

    Basic Information

    Device Name
    CALIBRATORS, CARBON DIOXIDE
    K Number
    K780295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E.I. DUPONT DE NEMOURS & CO., INC.
    Date Received
    February 21, 1978
    Decision Date
    April 5, 1978
    Product Code
    JIT
    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
    JIT Calibrator, Secondary

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