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

    REVISED LABELING FOR TDX BARBITURATES

    K Number: K874483 · Decision Nov 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    883
    Review Days
    24

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    Basic Information

    Device Name
    REVISED LABELING FOR TDX BARBITURATES
    K Number
    K874483
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Abbott Laboratories
    Date Received
    October 30, 1987
    Decision Date
    November 23, 1987
    Product Code
    DIS
    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
    DIS Enzyme Immunoassay, Barbiturate

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