BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Xprecia Prime Coagulation System

    K Number: K230802 · Decision Mar 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    126
    Applicant Total
    1
    Review Days
    358

    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
    Xprecia Prime Coagulation System
    K Number
    K230802
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    864.7750
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Universal Biosensors Pty, Ltd.
    Date Received
    March 23, 2023
    Decision Date
    March 15, 2024
    Product Code
    GJS
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GJS Test, Time, Prothrombin

    Similar 510(k) Clearances

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

    CoaguChek XS Plus System

    FDA 510(k)
    FDA Class 2 ·Hematology

    microINR System

    FDA 510(k)
    FDA Class 2 ·Hematology

    microINR System

    FDA 510(k)
    FDA Class 2 ·Hematology

    i-STAT PTplus Cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Hematology

    microINR System

    FDA 510(k)
    FDA Class 2 ·Hematology

    STA- NeoPTimal

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all