The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray Pneumonia Panel.
| Device ID | K212727 |
| 510k Number | K212727 |
| Device Name: | FilmArray Pneumonia Panel |
| Classification | Respiratory Panel |
| Applicant | BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108 |
| Contact | Kevin Bourzac |
| Correspondent | Kevin Bourzac BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108 |
| Product Code | QDP |
| CFR Regulation Number | 866.3985 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-27 |
| Decision Date | 2021-09-22 |