BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇨🇦 Canada

    TAG-IT CYSTIC FIBROSIS KIT

    K Number: DEN050004 · Decision May 9, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    34

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    Basic Information

    Device Name
    TAG-IT CYSTIC FIBROSIS KIT
    K Number
    DEN050004
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    866.5900
    Medical Specialty
    Immunology
    Decision
    Unknown
    Applicant
    Tm Bioscience Corporation
    Date Received
    April 5, 2005
    Decision Date
    May 9, 2005
    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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    Other Clearances by Tm Bioscience Corporation

    K Number Device Name
    K060627 TAG-IT CYSTIC FIBROSIS KIT