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

    ROCHE ONLINE TDM VALPROIC ACID

    K Number: K032049 · Decision Aug 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    34
    Applicant Total
    264
    Review Days
    51

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    Basic Information

    Device Name
    ROCHE ONLINE TDM VALPROIC ACID
    K Number
    K032049
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Corp.
    Date Received
    July 2, 2003
    Decision Date
    August 22, 2003
    Product Code
    LEG
    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
    LEG Enzyme Immunoassay, Valproic Acid

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