510(k) K243822
- Device
- BioFire Warrior Panel; BioFire Warrior Panel Control Kit
- Applicant
- Biofire Defense, LLC
- 510(k) number
- K243822
- Product code
- PRD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-12
- Date received
- 2024-12-12
- Review panel
- Immunology
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- David Rabiger
- Address
- 79 W 4500 S Suite 14 Salt Lake City UT US 84107 84107
FDA Registration Numbers#
- 3010770794