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

    DART PHENOBARBITAL ASSAY SYSTEM

    K Number: K864612 · Decision Jan 13, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    101
    Review Days
    50

    Basic Information

    Device Name
    DART PHENOBARBITAL ASSAY SYSTEM
    K Number
    K864612
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3660
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Coulter Electronics, Inc.
    Date Received
    November 24, 1986
    Decision Date
    January 13, 1987
    Product Code
    LFN
    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
    LFN Nephelometric Inhibition Immunoassay, Phenobarbital

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