510(k) clearance
DASH Flu A/B Test
- 510(k) number
- K261347
- Applicant
- Nuclein, LLC
- Decision date
- Oct 21, 2026
- Date received
- Apr 24, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Product code
- OCC
- Device type
- Respiratory Virus Panel Nucleic Acid Assay System
- Device class
- Class II
- Regulation
- 21 CFR 866.3980
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Austin, TX, US