K251742
- 510(k) number
- K251742
- Device name
- VELO Respiratory Test
- Applicant
- Lex Diagnostics Limited GB
- Product code
- QOF — Multi-Target Respiratory Specimen Nucleic Acid Test
- Decision date
- 2026-02-13
- Date received
- 2025-06-06
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251742.pdf
Official FDA record: K251742
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.