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

    OVA1 TEST

    K Number: DEN090004 · Decision Sep 11, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    51

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    OVA1 TEST
    K Number
    DEN090004
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    866.6050
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Unknown
    Applicant
    Vermillion
    Date Received
    July 22, 2009
    Decision Date
    September 11, 2009
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ONX), ordered by most recent decision date.

    ROMA Calculation Tool Using Elecsys Assays

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Lumipulse G ROMA

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ARCHITECT ROMA

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OVA1 Next Generation

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ROMA (HE4 EIA + ARCHITECT CA 125 II)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all