510(k) K133582 ยท GGN Plasma, Coagulation Control
HEMOSIL D-DIMER HS 500 CONTROL
| Applicant | Instrumentation Laboratory, Bedford MA, US |
| Decision | Substantially Equivalent, Aug 15, 2014 |
| Received | Nov 21, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133582
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.