K-number	K230802
Device name	Xprecia Prime Coagulation System
Applicant	Universal Biosensors Pty, Ltd.
Product code	GJS
Device class	Class II
Decision date	Mar 15, 2024
Decision	Substantially Equivalent
Regulation	864.7750

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Source

View the full FDA submission: accessdata.fda.gov

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Xprecia Prime Coagulation System

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