Biofire Diagnostics, LLC (Biomerieux) is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biofire Diagnostics, LLC (Biomerieux) - FDA 510(k) Cleared Devices
Recent clearances: BIOFIRE FILMARRAY Tropical Fever Panel, BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel)
2
Total
2
Cleared
0
Denied
Biofire Diagnostics, LLC (Biomerieux) has 2 FDA 510(k) cleared medical devices. Based in Salt Lake City, US.
Latest FDA clearance: Dec 2024. Active since 2024. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Biofire Diagnostics, LLC (Biomerieux) Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Biofire Diagnostics, LLC (Biomerieux)
2 devices