BioFire Warrior Panel; BioFire Warrior Panel Control Kit
K-Number: K243822 · 2025-03-12
ApplicantBiofire Defense, LLC
Decision Date2025-03-12
Product CodePRD
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
BioFire Warrior Panel; BioFire Warrior Panel Control Kit is a medical device manufactured by Biofire Defense, LLC. It received FDA 510(k) clearance on 2025-03-12 under approval number K243822. The device is classified under product code PRD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BioFire Warrior Panel; BioFire Warrior Panel Control Kit?
BioFire Warrior Panel; BioFire Warrior Panel Control Kit is a medical device that received FDA 510(k) clearance on 2025-03-12. It is manufactured by Biofire Defense, LLC. The 510(k) number is K243822.
When was BioFire Warrior Panel; BioFire Warrior Panel Control Kit approved by the FDA?
BioFire Warrior Panel; BioFire Warrior Panel Control Kit received FDA 510(k) clearance on 2025-03-12, under approval number K243822.
What company makes BioFire Warrior Panel; BioFire Warrior Panel Control Kit?
BioFire Warrior Panel; BioFire Warrior Panel Control Kit is manufactured by Biofire Defense, LLC.
What is the FDA product code for BioFire Warrior Panel; BioFire Warrior Panel Control Kit?
The FDA product code for BioFire Warrior Panel; BioFire Warrior Panel Control Kit is PRD.
Related Clinical Trials
Other Devices by Biofire Defense, LLC
Related Devices (Code: PRD)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.