510(k) K181324 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, Nov 15, 2018 |
| Received | May 18, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181324
| 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 |
| Feb 6, 2024 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit) Open, Classified |
QDS | None listed |
| Jun 7, 2021 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel plus (Pneumoplus)
Part Numbers:
Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit)
Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit) Terminated |
QDS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.