K243822
- 510(k) number
- K243822
- Device name
- BioFire Warrior Panel; BioFire Warrior Panel Control Kit
- Applicant
- Biofire Defense, LLC UT · US
- Product code
- PRD not yet in the FDA classification database
- Decision date
- 2025-03-12
- Date received
- 2024-12-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
510(k) Summary (official FDA PDF): K243822.pdf
Official FDA record: K243822
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.