K261475
- 510(k) number
- K261475
- Device name
- BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
- Applicant
- Biofire Defense, LLC UT · US
- Product code
- PMN — Assayed External Control Material For Microbiology N
- Decision date
- 2026-07-17
- Date received
- 2026-05-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K261475.pdf
Official FDA record: K261475
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.