510(k) K183166 ยท MDB System, Blood Culturing
BacT/ALERT FA Plus; BacT/ALERT PF Plus
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Feb 11, 2019 |
| Received | Nov 15, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183166
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.