510(k) K180966 ยท QDP Respiratory Panel
FilmArray Pneumonia Panel
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Nov 9, 2018 |
| Received | Apr 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180966
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2024 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit) Open, Classified |
QBH | None listed |
| Aug 21, 2023 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only Open, Classified |
QBH | None listed |
| Jun 7, 2021 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel (Pneumo)
Part Numbers:
Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit)
Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit) Terminated |
QBH | None listed |
| Apr 16, 2021 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144 Terminated |
QBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.