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

    ACS PHENYTOIN ASSAY

    K Number: K955873 · Decision Mar 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    14
    Applicant Total
    125
    Review Days
    76

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    Basic Information

    Device Name
    ACS PHENYTOIN ASSAY
    K Number
    K955873
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ciba Corning Diagnostics Corp.
    Date Received
    December 26, 1995
    Decision Date
    March 11, 1996
    Product Code
    LGR
    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
    LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)

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