BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Somatic Gene Mutation Detection System

    PMA: P110020 · Supplement: S003 · Decision Sep 4, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Somatic Gene Mutation Detection System
    Trade Name
    COBAS 4800 BRAF V600 MUTATION TEST
    PMA Number
    P110020
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    OWD
    Generic Name
    Somatic gene mutation detection system
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 4, 2012
    Date Received
    December 12, 2011
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE DNA SYNTHESIZER INSTRUMENT PLATFORM FOR CERTAIN VIALED MASTER MIX AND PROBE REAGENT COMPONENTS.

    Classifications

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

    Product Code Device Name
    OWD Somatic Gene Mutation Detection System