510(k) K974566 ยท GJS Test, Time, Prothrombin
MDA SIMPLASTIN HTF
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Feb 24, 1998 |
| Received | Dec 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974566
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 18, 2005 | BIOMERIEUX, INC. Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704 Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.