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

    DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD

    K Number: K904301 · Decision Nov 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    28
    Applicant Total
    253
    Review Days
    51

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    Basic Information

    Device Name
    DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD
    K Number
    K904301
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3830
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    September 19, 1990
    Decision Date
    November 9, 1990
    Product Code
    DKJ
    Advisory Committee
    Clinical Toxicology
    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
    DKJ Colorimetry, Salicylate

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