K243463
- 510(k) number
- K243463
- Device name
- BIOFIRE FILMARRAY Tropical Fever Panel
- Applicant
- Biofire Diagnostics, LLC (Biomerieux) UT · US
- Product code
- QMV — Device To Detect And Identify Selected Microbial Age
- Decision date
- 2024-12-05
- Date received
- 2024-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243463.pdf
Official FDA record: K243463
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.