K240280
- 510(k) number
- K240280
- Device name
- Nano-Check RSV Test
- Applicant
- Nano-Ditech Corporation NJ · US
- Product code
- GQG — Antigen, Cf (Including Cf Controls), Respiratory Syn
- Decision date
- 2024-07-30
- Date received
- 2024-02-01
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K240280.pdf
Official FDA record: K240280
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.