The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray Pneumonia Panel.
| Device ID | K180966 |
| 510k Number | K180966 |
| Device Name: | FilmArray Pneumonia Panel |
| Classification | Lower Respiratory Microbial Nucleic Acid Detection System |
| Applicant | BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108 |
| Contact | Kristen J. Kanack |
| Correspondent | Kristen J. Kanack BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108 |
| Product Code | QBH |
| CFR Regulation Number | 866.3985 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-13 |
| Decision Date | 2018-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815381020185 | K180966 | 000 |
| 00815381020178 | K180966 | 000 |