BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack

    K Number: K231525 · Decision Aug 9, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    10
    Applicant Total
    16
    Review Days
    75

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    Basic Information

    Device Name
    VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
    K Number
    K231525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho Clinical Diagnostics
    Date Received
    May 26, 2023
    Decision Date
    August 9, 2023
    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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