BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    THE CDI(R) SYSTEM 400

    K Number: K890113 · Decision May 23, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    8
    Review Days
    132

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    Basic Information

    Device Name
    THE CDI(R) SYSTEM 400
    K Number
    K890113
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2230
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Cardiovascular Devices, Inc.
    Date Received
    January 11, 1989
    Decision Date
    May 23, 1989
    Product Code
    DJY
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DJY Ion-Exchange Chromatography

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    Other Clearances by Cardiovascular Devices, Inc.

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