510(k) K212727 ยท QDP Respiratory Panel
FilmArray Pneumonia Panel
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Sep 22, 2021 |
| Received | Aug 27, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212727
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.