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

    EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95

    K Number: K864553 · Decision Jan 8, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    55
    Applicant Total
    288
    Review Days
    50

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    Basic Information

    Device Name
    EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95
    K Number
    K864553
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    November 19, 1986
    Decision Date
    January 8, 1987
    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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