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

    CEDIA(R) CARBAMAZEPINE ASSAY

    K Number: K914857 · Decision Jan 15, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    55
    Applicant Total
    107
    Review Days
    78

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    Basic Information

    Device Name
    CEDIA(R) CARBAMAZEPINE ASSAY
    K Number
    K914857
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Microgenics Corp.
    Date Received
    October 29, 1991
    Decision Date
    January 15, 1992
    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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