510(k) K220870 ยท QMV Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
| Applicant | Biofire Defense, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 20, 2022 |
| Received | Mar 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220870
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.