510(k) K020931 ยท MDB System, Blood Culturing
BACT/ALERT SA CULTURE BOTTLE
| Applicant | bioMerieux, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Apr 18, 2002 |
| Received | Mar 22, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020931
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2013 | bioMerieux, Inc. BacT/ALERT SA Blood Culture Bottle.
The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids Terminated |
MDB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.