BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    Idylla MSI Test

    K Number: K211181 · Decision Feb 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    678

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    Basic Information

    Device Name
    Idylla MSI Test
    K Number
    K211181
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1866
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biocartis NV
    Date Received
    April 20, 2021
    Decision Date
    February 27, 2023
    Product Code
    PZJ
    Advisory Committee
    Immunology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PZJ Lynch Syndrome Test System

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