510(k) K191967 ยท QBH Lower Respiratory Microbial Nucleic Acid Detection System
Unyvero LRT BAL Application
| Applicant | Curetis GmbH, Holzgerlingen, DE |
| Decision | Substantially Equivalent, Dec 20, 2019 |
| Received | Jul 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191967
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.