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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, time, prothrombin
510(k) Number K230802
Device Name Xprecia Prime Coagulation System
Applicant
Universal Biosensors Pty Ltd
1 Corporate Avenue
Rowville,  AU 3178
Applicant Contact Nosheen Hameed
Correspondent
Universal Biosensors Pty Ltd
1 Corporate Avenue
Rowville,  AU 3178
Correspondent Contact Nick Bliesner
Regulation Number864.7750
Classification Product Code
GJS  
Date Received03/23/2023
Decision Date 03/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
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