510(k) K160885 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
HemosIL D-Dimer HS
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Oct 27, 2016 |
| Received | Mar 31, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160885
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.