510(k) K050016 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
HEMOCHRON SIGNATURE ELITE
| Applicant | International Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, Feb 10, 2005 |
| Received | Jan 4, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050016
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.