510(k) K260909 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1); Sonoclot Coagulation & Platelet Function Analzyer System with Sonoclot Viewer (SCP2); Sonoclot Coagulation Analyzer System with Sonoclot Viewer (SC1)
| Applicant | Sienco, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Oct 27, 2026 |
| Received | Mar 19, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260909
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.