Cleared Dual Track

Xprecia Prime Coagulation System

K230802 · Universal Biosensors Pty, Ltd. · Hematology
Mar 2024
Decision
358d
Days
Class 2
Risk

About This 510(k) Submission

K230802 is an FDA 510(k) clearance for the Xprecia Prime Coagulation System, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Universal Biosensors Pty, Ltd. (Rowville, AU). The FDA issued a Cleared decision on March 15, 2024, 358 days after receiving the submission on March 23, 2023. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K230802 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2023
Decision Date March 15, 2024
Days to Decision 358 days
Submission Type Dual Track
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750