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

    PHENYTOIN KIT FLUORESCENCE POLARIZATION

    K Number: K842586 · Decision Sep 26, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    14
    Applicant Total
    19
    Review Days
    85

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    Basic Information

    Device Name
    PHENYTOIN KIT FLUORESCENCE POLARIZATION
    K Number
    K842586
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Windsor Laboratories, Inc.
    Date Received
    July 3, 1984
    Decision Date
    September 26, 1984
    Product Code
    LGR
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)

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