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510(k) K230802

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

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

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