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

    ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL

    K Number: K101305 · Decision Oct 29, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    17
    Review Days
    172

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    Basic Information

    Device Name
    ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
    K Number
    K101305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ark Diagnostics, Inc.
    Date Received
    May 10, 2010
    Decision Date
    October 29, 2010
    Product Code
    ORH
    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
    ORH Lamotrigine Assay

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