BIOFIRE FILMARRAY Tropical Fever Panel— 510(k) K243463
Substantially EquivalentBiofire Diagnostics, LLC (Biomerieux)
FDA 510(k) clearance K243463 for BIOFIRE FILMARRAY Tropical Fever Panel, Substantially Equivalent on 2024-12-05. Applicant: Biofire Diagnostics, LLC (Biomerieux).
Clearance details
- Applicant
- Biofire Diagnostics, LLC (Biomerieux)
- Product code
- Code QMV
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake City, UT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.