510(k) K040843 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
HEMOSIL VON WILLEBRAND ACTIVITY
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Apr 30, 2004 |
| Received | Apr 1, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040843
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2012 | Instrumentation Laboratory Co. Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit
Part Number: 0020004700
The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Terminated |
GGP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.