BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    MODIFICATION TO FIDIS VASCULITIS, MODEL MX007

    K Number: K070458 · Decision Dec 21, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    10
    Review Days
    308

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    Basic Information

    Device Name
    MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
    K Number
    K070458
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomedical Diagnostics (Bmd) SA
    Date Received
    February 16, 2007
    Decision Date
    December 21, 2007
    Product Code
    MOB
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

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    Other Clearances by Biomedical Diagnostics (Bmd) SA

    K Number Device Name
    K102607 FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS
    K100917 FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
    K071210 MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
    K061794 FIDIS TM THYRO, MODEL MX002
    K060380 FIDIS DSDNA
    K053383 FIDIS CELIAC
    K053653 FIDIS CONNECTIVE 10, MODEL MX006
    K053012 FIDIS VASCULITIS, MODEL MX007
    K050286 FIDIS CONNECTIVE 8