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

    AESKULISA GLIA A AND AESKULISA GLIA G

    K Number: K052439 · Decision Feb 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    41
    Applicant Total
    9
    Review Days
    154

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    Basic Information

    Device Name
    AESKULISA GLIA A AND AESKULISA GLIA G
    K Number
    K052439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aesku Diagnostics
    Date Received
    September 6, 2005
    Decision Date
    February 7, 2006
    Product Code
    MST
    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
    MST Antibodies, Gliadin

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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
    K041628 AESKULISA DS DNA G
    K041753 AESKULISA ENA 6 S