Nano-Check Influenza+COVID-19 Dual Test— 510(k) K243561
Substantially EquivalentNano-Ditech Corporation
FDA 510(k) clearance K243561 for Nano-Check Influenza+COVID-19 Dual Test, Substantially Equivalent on 2025-06-17. Applicant: Nano-Ditech Corporation. Device class: 2.
Clearance details
- Applicant
- Nano-Ditech Corporation
- Product code
- Code SCA
- Device class
- Class 2
- Regulation
- 21 CFR 866.3987
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Cranbury, NJ, US
Recent devices under product code SCA
view all- K261212 — Flowflex Plus RSV + Flu A/B + COVID Rapid Test
- K251085 — iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro
- K251092 — iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
- K251538 — Status COVID-19/Flu A&B
- K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test
More clearances from Nano-Ditech Corporation
view allData sourced from openFDA. This site is unofficial and independent of the FDA.