510(k) K243822

BioFire Warrior Panel; BioFire Warrior Panel Control Kit by Biofire Defense, LLC — Product Code PRD

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