K243222
- 510(k) number
- K243222
- Device name
- BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
- Applicant
- Biofire Diagnostics, LLC (Biomerieux) UT · US
- Product code
- QDS — Mers-Cov And Common Respiratory Pathogens Semi-Quant
- Decision date
- 2024-11-06
- Date received
- 2024-10-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Pathology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243222.pdf
Official FDA record: K243222
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.