510(k) K090209 ยท KFF Assay, Heparin
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Jun 2, 2009 |
| Received | Jan 28, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090209
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2024 | Instrumentation Laboratory ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing.
Part Number: 0000880311 Open, Classified |
KFF | None listed |
| Sep 30, 2024 | Instrumentation Laboratory ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing.
Part Number: 0001000311 Open, Classified |
KFF | None listed |
| Sep 30, 2024 | Instrumentation Laboratory ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing.
Part Number: 0000880311R Open, Classified |
KFF | None listed |
| Sep 30, 2024 | Instrumentation Laboratory ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing.
Part Number: 0001000311R Open, Classified |
KFF | None listed |
| Aug 25, 2021 | Instrumentation Laboratory HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL C Open, Classified |
KFF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.