510(k) K964946 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
SYSMEX CA-1000/SYSMEX CA-5000
| Applicant | Sysmex Corp., Long Grove IL, US |
| Decision | Substantially Equivalent, Mar 18, 1997 |
| Received | Dec 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964946
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.