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

    AESKUSLIDES ANA HEP-2

    K Number: K120889 · Decision Oct 15, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    109
    Applicant Total
    9
    Review Days
    206

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    Basic Information

    Device Name
    AESKUSLIDES ANA HEP-2
    K Number
    K120889
    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
    March 23, 2012
    Decision Date
    October 15, 2012
    Product Code
    DHN
    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
    DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

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    Other Clearances by Aesku Diagnostics

    K Number Device Name
    K132082 AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
    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
    K041753 AESKULISA ENA 6 S