510(k) K173202 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
| Applicant | Sekisui Medical Co., Ltd., Chuo-Ku, JP |
| Decision | Substantially Equivalent, May 9, 2018 |
| Received | Oct 2, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173202
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.