510(k) K241652 · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
DASH® SARS-CoV-2 & Flu A/B Test
| Applicant | Nuclein, LLC, Austin TX, US |
| Decision | Substantially Equivalent, Dec 20, 2024 |
| Received | Jun 7, 2024 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K241652
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2026 | Nuclein LLC Brand Name: DASH Rapid PCR Instrument
Product Name: DASH Rapid PCR Instrument
Model/Catalog Number: SG-0002
Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6
Product Description: The DASH Rapid PCR Instrum Open, Classified |
NSU | None listed |
| Aug 3, 2026 | Nuclein LLC Brand Name: DASH Rapid PCR Instrument
Product Name: DASH Rapid PCR Instrument
Model/Catalog Number: SG-0002
Software Version: 6.0.2
Product Description: The DASH Rapid PCR Instrument (DASH Instrument) Open, Classified |
NSU | None listed |
| Aug 6, 2025 | Nuclein LLC DASH SARS-CoV-2 & Flu A/B Test
Model/Catalog Number: SG-0006
combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided t Open, Classified |
QOF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.