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

    QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS

    K Number: K062966 · Decision Jan 12, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    28
    Review Days
    105

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    Basic Information

    Device Name
    QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
    K Number
    K062966
    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
    September 29, 2006
    Decision Date
    January 12, 2007
    Product Code
    ORH
    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
    ORH Lamotrigine Assay

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