Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Xprecia Prime Coagulation System

K-Number: K230802 · 2024-03-15

ApplicantUniversal Biosensors Pty, Ltd.
Decision Date2024-03-15
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Xprecia Prime Coagulation System is a medical device manufactured by Universal Biosensors Pty, Ltd.. It received FDA 510(k) clearance on 2024-03-15 under approval number K230802. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xprecia Prime Coagulation System?

Xprecia Prime Coagulation System is a medical device that received FDA 510(k) clearance on 2024-03-15. It is manufactured by Universal Biosensors Pty, Ltd.. The 510(k) number is K230802.

When was Xprecia Prime Coagulation System approved by the FDA?

Xprecia Prime Coagulation System received FDA 510(k) clearance on 2024-03-15, under approval number K230802.

What company makes Xprecia Prime Coagulation System?

Xprecia Prime Coagulation System is manufactured by Universal Biosensors Pty, Ltd..

What is the FDA product code for Xprecia Prime Coagulation System?

The FDA product code for Xprecia Prime Coagulation System is GJS.

Related Clinical Trials

NCT03735667 ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement ACTIVE_NOT_RECRUITING NCT05608408 PRIME: PReservIng Memory in Epilepsy RECRUITING NCT05393180 CONVERGE Post-Approval Study (PAS) ACTIVE_NOT_RECRUITING NCT06751355 Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): A Device Feasibility Trial RECRUITING

Related Devices (Code: GJS)

K151964Xprecia Stride Coagulation System, Xprecia System PT ControlsSiemens Healthcare Diagnostics K170960CoaguChek Vantus SystemRoche Diagnostics K180684CoaguChek XS Plus SystemRoche Diagnostics K180693CoaguChek XS Pro SystemRoche Diagnostics K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc. K180780microINR SystemIline Microsystems, S.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑