Medical Device Manufacturer · AU , Rowville

Universal Biosensors Pty, Ltd.

1 submissions · 1 cleared · Since 2024
1
Total
1
Cleared
0
Denied

Universal Biosensors Pty, Ltd. — FDA 510(k) Submissions

Universal Biosensors Pty, Ltd. has submitted 1 FDA 510(k) premarket notifications since 2024, of which 1 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Test, Time, Prothrombin . Use the specialty filter in the sidebar to narrow results.

1 devices
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All1 Hematology 1