K243822 is an FDA 510(k) clearance for the BioFire Warrior Panel..
Submitted by Biofire Defense, LLC (Salt Lake City, US). The FDA issued a Cleared decision on March 12, 2025, 90 days after receiving the submission on December 12, 2024.
This device falls under the Microbiology FDA review panel.
| 510(k) Number | K243822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2024 |
| Decision Date | March 12, 2025 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PRD |
| Device Class | - |