510(k) K243822
K243822 is an FDA 510(k) premarket notification submitted by Biofire Defense, LLC for the device "BioFire Warrior Panel; BioFire Warrior Panel Control Kit". The FDA issued a decision of Substantially Equivalent on March 12, 2025. Biofire Defense, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2025
- Date Received
- December 12, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No