510(k) K190405 ยท MDB System, Blood Culturing
BACT/ALERT MP Reagent System
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, May 15, 2019 |
| Received | Feb 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190405
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.