510(k) K980242 ยท KFF Assay, Heparin
IL TEST HEPARIN
| Applicant | Instrumentation Laboratory CO, Lexington MA, US |
| Decision | Substantially Equivalent, Mar 19, 1998 |
| Received | Jan 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980242
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.