K151964 is an FDA 510(k) clearance for the Xprecia Stride Coagulation System, Xprecia System PT Controls. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).
Submitted by Siemens Healthcare Diagnostics (Norowood, US). The FDA issued a Cleared decision on September 30, 2016, 442 days after receiving the submission on July 16, 2015.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.
| 510(k) Number | K151964 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2015 |
| Decision Date | September 30, 2016 |
| Days to Decision | 442 days |
| Submission Type | Traditional |
| 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 |