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

    Lumipulse G CA19-9-N

    K Number: K200997 · Decision May 14, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    10
    Applicant Total
    45
    Review Days
    28

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    Basic Information

    Device Name
    Lumipulse G CA19-9-N
    K Number
    K200997
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujirebio Diagnostics,Inc.
    Date Received
    April 16, 2020
    Decision Date
    May 14, 2020
    Product Code
    NIG
    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
    NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

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