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

    AXSYM PHENOBARBITAL

    K Number: K940596 · Decision Jun 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    883
    Review Days
    131

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    Basic Information

    Device Name
    AXSYM PHENOBARBITAL
    K Number
    K940596
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3660
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Laboratories
    Date Received
    February 10, 1994
    Decision Date
    June 21, 1994
    Product Code
    LGQ
    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
    LGQ Fluorescence Polarization Immunoassay, Phenobarbital

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