BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit— 510(k) K261475
Substantially EquivalentBiofire Defense, LLC
FDA 510(k) clearance K261475 for BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit, Substantially Equivalent on 2026-07-17. Applicant: Biofire Defense, LLC.
Clearance details
- Applicant
- Biofire Defense, LLC
- Product code
- Code PMN
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.