510(k) K011235 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
| Applicant | Dade Behring, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jul 20, 2001 |
| Received | Apr 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011235
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.