# Universal Biosensors Pty, Ltd.

- Location (FDA's records): Rowville, AU
- FDA decisions: 1 (2024–2024): 1 510(k) clearance
- Product codes: GJS (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)

## Recent decisions
- K230802: Xprecia Prime Coagulation System (Mar 15, 2024)

Source page: https://510kreport.com/company/universal-biosensors