510(k) K864283 ยท GJS Test, Time, Prothrombin
SIMPLASTIN EXCEL
| Applicant | Organon Teknika Corp., Kensington TX, US |
| Decision | Substantially Equivalent, Dec 4, 1986 |
| Received | Oct 30, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864283
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2003 | Biomerieux, Inc. Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. Durham, NC 27704. The product consists of two vials, a thromboplastin reagent and a diluent ( the vials are mi Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.