510(k) K903505 ยท MDB System, Blood Culturing
BACT/ALERT (TM)
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Mar 12, 1991 |
| Received | Aug 3, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903505
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2007 | bioMerieux, Inc. BacT/ALERT Classic System 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 |
| Sep 7, 2005 | BIOMERIEUX, INC. Bac T/ALERT 3D Control Module Terminated |
MDB | None listed |
| Sep 7, 2005 | BIOMERIEUX, INC. Bac T/ALERT 3D Combination Module Terminated |
MDB | None listed |
| Sep 7, 2005 | BIOMERIEUX, INC. Bac T/ALERT 3D 60 Terminated |
MDB | None listed |
| Feb 1, 2005 | bioMerieux BacT/ALERT(BTA) Classic instruments. Terminated |
MDB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.