510(k) K243463
- Device
- BIOFIRE FILMARRAY Tropical Fever Panel
- Applicant
- Biofire Diagnostics, LLC (Biomerieux)
- 510(k) number
- K243463
- Product code
- QMV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-05
- Date received
- 2024-11-08
- Regulation
- 866.3966
- Classification name
- Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Karli Plenert
- Address
- 515 Colorow Dr. Salt Lake City UT US 84108 84108
FDA Registration Numbers
- 3002773840
- 3010770794