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

    CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196

    K Number: K041174 · Decision Jul 19, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    39
    Applicant Total
    8
    Review Days
    75

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    Basic Information

    Device Name
    CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196
    K Number
    K041174
    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
    May 5, 2004
    Decision Date
    July 19, 2004
    Product Code
    MVM
    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
    MVM Autoantibodies, Endomysial(Tissue Transglutaminase)

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    Other Clearances by Sweden Diagnostics (Germany) GmbH

    K Number Device Name
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    K042629 VARELISA SM ANTIBODIES, MODEL 18296
    K041357 VARELISA GLIADIN IGG ANTIBODIES
    K041173 CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996
    K041354 VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
    K041040 VARELISA MPO ANCA, MODEL 17648/17696