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

    CM-TRISACRYL M DEAE-TRISACRYL M

    K Number: K842028 · Decision Jun 7, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    8
    Applicant Total
    52
    Review Days
    20

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    Basic Information

    Device Name
    CM-TRISACRYL M DEAE-TRISACRYL M
    K Number
    K842028
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2230
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Lkb Instruments, Inc.
    Date Received
    May 18, 1984
    Decision Date
    June 7, 1984
    Product Code
    KEA
    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
    KEA Resins, Ion-Exchange

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