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

    ROMA (HE4 EIA + ARCHITECT CA 125 II)

    K Number: K103358 · Decision Sep 1, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    45
    Review Days
    289

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    Basic Information

    Device Name
    ROMA (HE4 EIA + ARCHITECT CA 125 II)
    K Number
    K103358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6050
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Fujirebio Diagnostics,Inc.
    Date Received
    November 16, 2010
    Decision Date
    September 1, 2011
    Product Code
    ONX
    Advisory Committee
    Obstetrics/Gynecology
    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
    ONX Ovarian Adnexal Mass Assessment Score Test System

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