BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    MASTALEX -MRSA, MODEL RST501

    K Number: K062864 · Decision Oct 18, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    23

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    Basic Information

    Device Name
    MASTALEX -MRSA, MODEL RST501
    K Number
    K062864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mast Group , Ltd.
    Date Received
    September 25, 2006
    Decision Date
    October 18, 2006
    Product Code
    MYI
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

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