BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AESKULISA TTG A AND AESKULISA TTG G

    K Number: K042644 · Decision Jun 1, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    39
    Applicant Total
    6
    Review Days
    247

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    Basic Information

    Device Name
    AESKULISA TTG A AND AESKULISA TTG G
    K Number
    K042644
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aesku, Inc.
    Date Received
    September 27, 2004
    Decision Date
    June 1, 2005
    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 Aesku, Inc.

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    K062217 AESKULSKA BETA2-GLYCO-A
    K051492 AESKULISA ASCA A
    K040953 AESKULISA ANA HEP-2
    K040463 AESKULISA CARDIOLIPIN AGM
    K032469 AESKULISA ANA 8PRO