BEUDAMED
    Product Code: MSL FDA class 2 21 CFR 862.3350

    System, Test, Topiramatee

    Clinical Toxicology

    A Topiramate Test System is an in vitro diagnostic device used to measure the concentration of topiramate, an antiseizure and antimigraine medication, in patient blood or serum samples to support therapeutic drug monitoring. It is classified as FDA Class 2, requiring 510(k) premarket clearance, with product code MSL under 21 CFR 862.3350 in the Clinical Toxicology specialty. The device is not an implant and does not carry a life-sustaining designation.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MSL
    Device Class
    FDA class 2
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K970510 INNOFLOUR TOPIRAMATE REAGENT SET