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

    QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS

    K Number: K051211 · Decision Nov 18, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    28
    Review Days
    191

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    Basic Information

    Device Name
    QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
    K Number
    K051211
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seradyn, Inc.
    Date Received
    May 11, 2005
    Decision Date
    November 18, 2005
    Product Code
    NWM
    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
    NWM Immunoassay, Anti-Seizure Drug

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