K241652
- 510(k) number
- K241652
- Device name
- DASH® SARS-CoV-2 & Flu A/B Test
- Applicant
- Nuclein, LLC TX · US
- Product code
- QOF — Multi-Target Respiratory Specimen Nucleic Acid Test
- Decision date
- 2024-12-20
- Date received
- 2024-06-07
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K241652.pdf
Official FDA record: K241652
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.