K170883 is an FDA 510(k) clearance for the FilmArray NGDS Warrior Panel..
Submitted by Biofire Defense, LLC (Salt Lake City, US). The FDA issued a Cleared decision on June 22, 2017, 90 days after receiving the submission on March 24, 2017.
This device falls under the Microbiology FDA review panel.
| 510(k) Number | K170883 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2017 |
| Decision Date | June 22, 2017 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PRD |
| Device Class | - |