K232954
- 510(k) number
- K232954
- Device name
- BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
- Applicant
- Biofire Diagnostics, LLC UT · US
- Product code
- QOF — Multi-Target Respiratory Specimen Nucleic Acid Test
- Decision date
- 2024-03-26
- Date received
- 2023-09-21
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232954.pdf
Official FDA record: K232954
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.