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

    EXTRELUT QE EXTRACTION COLUMNS

    K Number: K831027 · Decision May 16, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    8
    Applicant Total
    62
    Review Days
    47

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    Basic Information

    Device Name
    EXTRELUT QE EXTRACTION COLUMNS
    K Number
    K831027
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2230
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Emd Chemicals, Inc.
    Date Received
    March 30, 1983
    Decision Date
    May 16, 1983
    Product Code
    KEA
    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
    KEA Resins, Ion-Exchange

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