510(k) K882214 ยท GJS Test, Time, Prothrombin
SIMPLASTIN EXCEL S
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Jul 1, 1988 |
| Received | May 26, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882214
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2003 | Biomerieux, Inc. BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, 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.