BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    AESKU PR3

    K Number: K091859 · Decision Jun 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    9
    Review Days
    349

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    Basic Information

    Device Name
    AESKU PR3
    K Number
    K091859
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesku Diagnostics
    Date Received
    June 19, 2009
    Decision Date
    June 3, 2010
    Product Code
    MOB
    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
    MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

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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
    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
    K041753 AESKULISA ENA 6 S