510(k) K954468 ยท MDB System, Blood Culturing
MB/BACT MYCROBACTERIA DETECTION SYSTEM
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Jul 22, 1996 |
| Received | Sep 26, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954468
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2007 | bioMerieux, Inc. BacT/ALERT 3D Combo Systems Software, Blood Culturing System Terminated |
MDB | None listed |
| Mar 22, 2007 | bioMerieux, Inc. BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box 15969, Durham, NC 27704-0969 USA Terminated |
MDB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.