K240280 is an FDA 510(k) clearance for the Nano-Check™ RSV Test. This device is classified as a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I - General Controls, product code GQG).
Submitted by Nano-Ditech Corporation (Cranbury, US). The FDA issued a Cleared decision on July 30, 2024, 180 days after receiving the submission on February 1, 2024.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3480.
| 510(k) Number | K240280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2024 |
| Decision Date | July 30, 2024 |
| Days to Decision | 180 days |
| Submission Type | Dual Track |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GQG - Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3480 |