510(k) K020813 ยท MDB System, Blood Culturing
BACT/ALERT FA CULTURE BOTTLE
| Applicant | bioMerieux, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Apr 17, 2002 |
| Received | Mar 13, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020813
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 24, 2015 | bioMerieux, Inc. BacT/ALERT FA, bioMrieux, Inc.,
Product Usage:
BacT/ALERT Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aero Terminated |
MDB | None listed |
| May 24, 2011 | bioMerieux, Inc. BacT/ALERT - FA Reagent Bottle
The BacT/ALERT Microbial Detection System is used to determine if microorganisms are present in blood or other normally sterile body fluid samples taken from a patient s Terminated |
MDB | None listed |
| Mar 22, 2007 | bioMerieux, Inc. BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704 Terminated |
MDB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.