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

    ONLINE TDM Vancomycin Gen.3

    K Number: K152245 · Decision Jan 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    30
    Applicant Total
    14
    Review Days
    151

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    Basic Information

    Device Name
    ONLINE TDM Vancomycin Gen.3
    K Number
    K152245
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3950
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Operations (Rdo)
    Date Received
    August 10, 2015
    Decision Date
    January 8, 2016
    Product Code
    LEH
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    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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