510(k) K230802 ยท GJS Test, Time, Prothrombin
Xprecia Prime Coagulation System
| Applicant | Universal Biosensors Pty, Ltd., Rowville, AU |
| Decision | Substantially Equivalent, Mar 15, 2024 |
| Received | Mar 23, 2023 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K230802
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.