Universal Biosensors Pty, Ltd. is one of 80 FDA 510(k) medical device manufacturers from Australia in the dataset, ranked by real submission volume.
Universal Biosensors Pty, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Xprecia Prime Coagulation System
1
Total
1
Cleared
0
Denied
Universal Biosensors Pty, Ltd. has 1 FDA 510(k) cleared medical devices. Based in Rowville, AU.
Latest FDA clearance: Mar 2024. Active since 2024. Primary specialty: Hematology.
Browse the FDA 510(k) cleared devices submitted by Universal Biosensors Pty, Ltd. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Universal Biosensors Pty, Ltd.
1 devices