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

    AESKULISA ASCA A

    K Number: K051492 · Decision Nov 14, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    6
    Review Days
    161

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    Basic Information

    Device Name
    AESKULISA ASCA A
    K Number
    K051492
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5785
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aesku, Inc.
    Date Received
    June 6, 2005
    Decision Date
    November 14, 2005
    Product Code
    NBT
    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
    NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)

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    Other Clearances by Aesku, Inc.

    K Number Device Name
    K062217 AESKULSKA BETA2-GLYCO-A
    K042644 AESKULISA TTG A AND AESKULISA TTG G
    K040953 AESKULISA ANA HEP-2
    K040463 AESKULISA CARDIOLIPIN AGM
    K032469 AESKULISA ANA 8PRO