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

    CEDIA VANCOMYCIN ASSAY

    K Number: K032811 · Decision Nov 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    30
    Applicant Total
    107
    Review Days
    76

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    Basic Information

    Device Name
    CEDIA VANCOMYCIN ASSAY
    K Number
    K032811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3950
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microgenics Corp.
    Date Received
    September 9, 2003
    Decision Date
    November 24, 2003
    Product Code
    LEH
    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
    LEH Radioimmunoassay, Vancomycin

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