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510(k) K230802

Xprecia Prime Coagulation System by Universal Biosensors Pty, Ltd. — Product Code GJS

K230802 is an FDA 510(k) premarket notification submitted by Universal Biosensors Pty, Ltd. for the device "Xprecia Prime Coagulation System". The FDA issued a decision of Substantially Equivalent on March 15, 2024. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2024
Date Received
March 23, 2023
Clearance Type
Dual Track
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
Review Panel
HE
Submission Type

Other clearances for product code GJS

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  • K251564 — microINR System (July 21, 2025)
  • K243543 — microINR System (February 27, 2025)
  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 2023)
  • K231711 — microINR System (July 11, 2023)
  • K211485 — STA- NeoPTimal (December 23, 2022)
  • K212779 — Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (October 5, 2022)
  • K213426 — HemosIL ReadiPlasTin (August 16, 2022)
  • K201185 — microINR System (December 18, 2020)
  • K183255 — Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (February 21, 2019)

FDA data resources