DEN160048 is an FDA 510(k) submission for the FilmArray NGDS Warrior Panel..
Submitted by Biofire Defense, LLC (Salt Lake City, US). The FDA issued a Not Cleared (DENG) decision on February 14, 2017.
This device falls under the Microbiology FDA review panel.
| 510(k) Number | DEN160048 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | October 17, 2016 |
| Decision Date | February 14, 2017 |
| Days to Decision | 120 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Product Code | PRD |
| Device Class | - |