510(k) K170854 ยท LCO Platelet Factor 4 Radioimmunoassay
HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Sep 8, 2017 |
| Received | Mar 22, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170854
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2026 | Instrumentation Laboratory HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic Open, Classified |
LCO | None listed |
| Oct 10, 2026 | Instrumentation Laboratory HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only) Open, Classified |
LCO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.