510(k) K161312 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Sysmex Automated Blood Coagulation Analyzer CS-2100i
| Applicant | Siemens Healthcare Diagnostics Products GmbH, Marburg, DE |
| Decision | Substantially Equivalent, Sep 1, 2016 |
| Received | May 10, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161312
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.