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

    SDI PREPAX DILUKIT 29-1000

    K Number: K840044 · Decision Mar 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    21
    Applicant Total
    7
    Review Days
    63

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    Basic Information

    Device Name
    SDI PREPAX DILUKIT 29-1000
    K Number
    K840044
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2540
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Scientific Distributors, Inc.
    Date Received
    January 6, 1984
    Decision Date
    March 9, 1984
    Product Code
    JJO
    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
    JJO Flame Emission Photometer For Clinical Use

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