510(k) K090563 ยท GGN Plasma, Coagulation Control
HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
| Applicant | Instrumentation Laboratory CO, Orangeburg NY, US |
| Decision | Substantially Equivalent, Oct 9, 2009 |
| Received | Mar 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090563
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.