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

    AESKULISA DS DNA G

    K Number: K041628 · Decision Oct 14, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    7
    Applicant Total
    9
    Review Days
    120

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    Basic Information

    Device Name
    AESKULISA DS DNA G
    K Number
    K041628
    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 16, 2004
    Decision Date
    October 14, 2004
    Product Code
    LSW
    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
    LSW Anti-Dna 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
    K041753 AESKULISA ENA 6 S