510(k) K153137 ยท LCO Platelet Factor 4 Radioimmunoassay
HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Jul 8, 2016 |
| Received | Oct 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153137
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.