510(k) K243222
- Device
- BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
- Applicant
- Biofire Diagnostics, LLC (Biomerieux)
- 510(k) number
- K243222
- Product code
- QDS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-06
- Date received
- 2024-10-07
- Regulation
- 866.4001
- Classification name
- Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Karli Plenert
- Address
- 515 Colorow Dr. Salt Lake City UT US 84108 84108
FDA Registration Numbers#
- 3002773840