DASH® SARS-CoV-2 & Flu A/B Test
FDA 510(k) clearance K241652 · decided 2024-12-20
Clearance details
- K-number
- K241652
- Device name
- DASH® SARS-CoV-2 & Flu A/B Test
- Applicant
- Nuclein, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-06-07
- Decision date
- 2024-12-20
- Days to decision
- 196 days
- Clearance type
- Dual Track
- Product code
- QOF
- Device class
- 2
- Regulation number
- 866.3981
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalo recall (Z-2861-2026) | Nuclein LLC | 2026-08-03 |
| DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu recall (Z-2274-2025) | Nuclein LLC | 2025-08-06 |