510(k) K202382 ยท PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
FilmArray Global Fever Panel External Control Kit
| Applicant | Biofire Defense, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Nov 20, 2020 |
| Received | Aug 20, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202382
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.