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

    DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD

    K Number: K911056 · Decision Apr 3, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    43
    Applicant Total
    253
    Review Days
    26

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    Basic Information

    Device Name
    DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD
    K Number
    K911056
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    March 8, 1991
    Decision Date
    April 3, 1991
    Product Code
    DIP
    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
    DIP Enzyme Immunoassay, Diphenylhydantoin

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