Nano-Check Influenza+COVID-19 Dual Test
FDA 510(k) clearance K243561 · decided 2025-06-17
Clearance details
- K-number
- K243561
- Device name
- Nano-Check Influenza+COVID-19 Dual Test
- Applicant
- Nano-Ditech Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-11-18
- Decision date
- 2025-06-17
- Days to decision
- 211 days
- Clearance type
- Dual Track
- Product code
- SCA
- Device class
- 2
- Regulation number
- 866.3987
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cranbury, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Nano-Ditech Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.