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

    AMES TDA CARBAMAZEPINE TEST

    K Number: K811952 · Decision Jul 15, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    55
    Applicant Total
    158
    Review Days
    8

    Basic Information

    Device Name
    AMES TDA CARBAMAZEPINE TEST
    K Number
    K811952
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    MILES LABORATORIES, INC.
    Date Received
    July 7, 1981
    Decision Date
    July 15, 1981
    Product Code
    KLT
    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
    KLT Enzyme Immunoassay, Carbamazepine

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