510(k) DEN200066 ยท QSN Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
BioFire Joint Infection (JI) Panel
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Unknown, Apr 29, 2022 |
| Received | Oct 27, 2020 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN200066
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.