510(k) K213362 ยท QVR Multiplex Nucleic Acid Detection System For Biothreat Agents
BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
| Applicant | Biofire Defense, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 22, 2023 |
| Received | Oct 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213362
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.