510(k) K083518 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Mar 13, 2009 |
| Received | Nov 26, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083518
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.