510(k) K222601 ยท QDS Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
FilmArray Pneumonia Panel plus
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 27, 2022 |
| Received | Aug 29, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K222601
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2025 | BioFire Diagnostics, LLC FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 Open, Classified |
QDS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.