K243561
- 510(k) number
- K243561
- Device name
- Nano-Check Influenza+COVID-19 Dual Test
- Applicant
- Nano-Ditech Corporation NJ · US
- Product code
- SCA — Multi-Analyte Respiratory Virus Antigen Detection Te
- Decision date
- 2025-06-17
- Date received
- 2024-11-18
- 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: K243561.pdf
Official FDA record: K243561
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.