510(k) K050513 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
MDA B.30
| Applicant | bioMerieux, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Apr 1, 2005 |
| Received | Mar 1, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050513
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.