510(k) K151964 ยท GJS Test, Time, Prothrombin
Xprecia Stride Coagulation System, Xprecia System PT Controls
| Applicant | Siemens Healthcare Diagnostics, Norowood MA, US |
| Decision | Substantially Equivalent, Sep 30, 2016 |
| Received | Jul 16, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151964
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.