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

    AESKULISA ANA 8PRO

    K Number: K032469 · Decision Dec 16, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    179
    Applicant Total
    6
    Review Days
    127

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    Basic Information

    Device Name
    AESKULISA ANA 8PRO
    K Number
    K032469
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aesku, Inc.
    Date Received
    August 11, 2003
    Decision Date
    December 16, 2003
    Product Code
    LLL
    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
    LLL Extractable Antinuclear Antibody, Antigen And Control

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    Other Clearances by Aesku, Inc.

    K Number Device Name
    K062217 AESKULSKA BETA2-GLYCO-A
    K051492 AESKULISA ASCA A
    K042644 AESKULISA TTG A AND AESKULISA TTG G
    K040953 AESKULISA ANA HEP-2
    K040463 AESKULISA CARDIOLIPIN AGM