510(k) K143178 ยท NSU Instrumentation For Clinical Multiplex Test Systems
FilmArray 2.0 System
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jan 30, 2015 |
| Received | Nov 4, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143178
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2024 | BioFire Diagnostics, LLC FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W Open, Classified |
NSU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.