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

    AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin

    K Number: K172461 · Decision Mar 23, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    2
    Review Days
    221

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    Basic Information

    Device Name
    AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
    K Number
    K172461
    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 GmbH & Co. KG
    Date Received
    August 14, 2017
    Decision Date
    March 23, 2018
    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 GmbH & Co. KG

    K Number Device Name
    K172348 AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10