510(k) K160068 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
FilmArray Respiratory Panel (RP) for use with FilmArray Torch
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Feb 8, 2016 |
| Received | Jan 13, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2024 | BioFire Diagnostics, LLC FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U Open, Classified |
OCC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.