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

    VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack

    K Number: K233581 · Decision May 8, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    71
    Applicant Total
    16
    Review Days
    183

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    Basic Information

    Device Name
    VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
    K Number
    K233581
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ortho Clinical Diagnostics
    Date Received
    November 7, 2023
    Decision Date
    May 8, 2024
    Product Code
    DHA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DHA System, Test, Human Chorionic Gonadotropin

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