BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

    PMA: P110012 · Supplement: S004 · Decision Jan 24, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
    Trade Name
    VYSIS ALK BREAK APART FISH PROBE KIT
    PMA Number
    P110012
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    OWE
    Generic Name
    Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 24, 2014
    Date Received
    August 29, 2013
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT LEICA BIOSYSTEMS IN SOLON MILLS, ILLINOIS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OWE Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement