510(k) K213464 ยท KFF Assay, Heparin
HemosIL Liquid Anti-Xa
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Oct 4, 2022 |
| Received | Oct 28, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213464
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2025 | Instrumentation Laboratory HemosIL LMW Heparin Controls;
Part Number: 0020300200; Open, Classified |
KFF | None listed |
| Jan 24, 2025 | Instrumentation Laboratory HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic Open, Classified |
KFF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.