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

    OPUS PHENYTOIN TEST SYSTEM

    K Number: K896868 · Decision Jan 2, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    14
    Applicant Total
    35
    Review Days
    26

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    Basic Information

    Device Name
    OPUS PHENYTOIN TEST SYSTEM
    K Number
    K896868
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Pb Diagnostic Systems, Inc.
    Date Received
    December 7, 1989
    Decision Date
    January 2, 1990
    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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