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

    VARELISA RECOMBI CTD SCREEN, MODEL 13096

    K Number: K050967 · Decision Jun 28, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    111
    Applicant Total
    8
    Review Days
    71

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    Basic Information

    Device Name
    VARELISA RECOMBI CTD SCREEN, MODEL 13096
    K Number
    K050967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sweden Diagnostics (Germany) GmbH
    Date Received
    April 18, 2005
    Decision Date
    June 28, 2005
    Product Code
    LJM
    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
    LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

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    Other Clearances by Sweden Diagnostics (Germany) GmbH

    K Number Device Name
    K050625 VARELISA RECOMBI ANA PROFILE, MODEL 18496
    K042629 VARELISA SM ANTIBODIES, MODEL 18296
    K041357 VARELISA GLIADIN IGG ANTIBODIES
    K041173 CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996
    K041174 CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196
    K041354 VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
    K041040 VARELISA MPO ANCA, MODEL 17648/17696