BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    VARELISA MPO ANCA, MODEL 17648/17696

    K Number: K041040 · Decision Jun 16, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    8
    Review Days
    55

    Basic Information

    Device Name
    VARELISA MPO ANCA, MODEL 17648/17696
    K Number
    K041040
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SWEDEN DIAGNOSTICS (GERMANY) GMBH
    Date Received
    April 22, 2004
    Decision Date
    June 16, 2004
    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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