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

    ONLINE TDM AMIKA

    K Number: K032279 · Decision Oct 10, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    264
    Review Days
    78

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    Basic Information

    Device Name
    ONLINE TDM AMIKA
    K Number
    K032279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3035
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Corp.
    Date Received
    July 24, 2003
    Decision Date
    October 10, 2003
    Product Code
    KLP
    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
    KLP Amikacin Serum Assay

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