510(k) K250965 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
| Applicant | Sysmex America, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Jun 2, 2025 |
| Received | Mar 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250965
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.