FDA.report

510(k) K230802

Device
Xprecia Prime Coagulation System
Applicant
Universal Biosensors Pty, Ltd.
510(k) number
K230802
Product code
GJS
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-15
Date received
2023-03-23
Regulation
864.7750
Classification name
Test, Time, Prothrombin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Dual Track
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Nosheen Hameed
Address
1 Corporate Ave. Rowville AU 3178 3178

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code GJS

510(k)DeviceApplicantDecision date
K253188CoaguChek XS Plus SystemRoche Diagnostics2025-10-24
K251564microINR SystemIline Microsystems, S.L.2025-07-21
K243543microINR SystemIline Microsystems, S.L.2025-02-27
K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott Laboratories2023-07-14
K231711microINR SystemIline Microsystems, S.L.2023-07-11
K211485STA- NeoPTimalDiagnostica Stago S.A.S2022-12-23
K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingCoagusense, Inc.2022-10-05
K213426HemosIL ReadiPlasTinInstrumentation Laboratory CO2022-08-16
K201185microINR SystemIline Microsystems, S.L.2020-12-18
K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc.2019-02-21
K180780microINR SystemIline Microsystems, S.L.2019-01-25
K180693CoaguChek XS Pro SystemRoche Diagnostics2018-04-19
K180684CoaguChek XS Plus SystemRoche Diagnostics2018-04-19
K170960CoaguChek Vantus SystemRoche Diagnostics2017-12-25
K151964Xprecia Stride Coagulation System, Xprecia System PT ControlsSiemens Healthcare Diagnostics2016-09-30