510(k) K050053 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
HEMORAM/AGGRAM ANALYZER
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jul 11, 2005 |
| Received | Jan 10, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050053
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.