510(k) K150678 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Sysmex Automated Blood Coagulation Analyzer CS-5100
| Applicant | Siemens Healthcare Diagnostic Products GmbH, Marburg, DE |
| Decision | Substantially Equivalent, Jan 11, 2016 |
| Received | Mar 16, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150678
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.