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

    DUPONT ACA VANCOMYCIN (VANC) METHOD

    K Number: K945125 · Decision Mar 10, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    30
    Applicant Total
    13
    Review Days
    142

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    Basic Information

    Device Name
    DUPONT ACA VANCOMYCIN (VANC) METHOD
    K Number
    K945125
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3950
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The DU Pont Co.
    Date Received
    October 19, 1994
    Decision Date
    March 10, 1995
    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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