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

    AESKULISA ENA 6 S

    K Number: K041753 · Decision Jul 14, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    179
    Applicant Total
    9
    Review Days
    15

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    Basic Information

    Device Name
    AESKULISA ENA 6 S
    K Number
    K041753
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aesku Diagnostics
    Date Received
    June 29, 2004
    Decision Date
    July 14, 2004
    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 Diagnostics

    K Number Device Name
    K132082 AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
    K120889 AESKUSLIDES ANA HEP-2
    K091859 AESKU PR3
    K091860 AESKULISA MPO, MODEL 30-7303US
    K081251 MODIFICATION TO AESKULISA DS DNA G
    K081104 AESKULISA ANA HEP-2, REF 30-7115US
    K052439 AESKULISA GLIA A AND AESKULISA GLIA G
    K041628 AESKULISA DS DNA G