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

    TDX(R)/TDXFLX(R) FREE PHENYTOIN II

    K Number: K950280 · Decision May 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    883
    Review Days
    98

    Basic Information

    Device Name
    TDX(R)/TDXFLX(R) FREE PHENYTOIN II
    K Number
    K950280
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Laboratories
    Date Received
    January 24, 1995
    Decision Date
    May 2, 1995
    Product Code
    MOJ
    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
    MOJ Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)

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