510(k) K060931 ยท GJS Test, Time, Prothrombin
HEMOSIL PT-FIBRINOGEN HS PLUS
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, May 2, 2006 |
| Received | Apr 5, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060931
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2014 | Instrumentation Laboratory Co. HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company.
A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determinati Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.