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

    ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800

    K Number: K051435 · Decision Jan 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    232

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    Basic Information

    Device Name
    ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800
    K Number
    K051435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5900
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clinical Micro Sensors
    Date Received
    June 1, 2005
    Decision Date
    January 19, 2006
    Product Code
    NUA
    Advisory Committee
    Immunology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

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