K230802 is an FDA 510(k) clearance for the Xprecia Prime Coagulation System. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).
Submitted by Universal Biosensors Pty, Ltd. (Rowville, AU). The FDA issued a Cleared decision on March 15, 2024, 358 days after receiving the submission on March 23, 2023.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.
| 510(k) Number | K230802 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2023 |
| Decision Date | March 15, 2024 |
| Days to Decision | 358 days |
| Submission Type | Dual Track |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GJS - Test, Time, Prothrombin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7750 |