DASH® SARS-CoV-2 & Flu A/B Test— 510(k) K241652

Substantially Equivalent

Nuclein, LLC

FDA 510(k) clearance K241652 for DASH® SARS-CoV-2 & Flu A/B Test, Substantially Equivalent on 2024-12-20. Applicant: Nuclein, LLC. Device class: 2.

Clearance details

Applicant: Nuclein, LLC
Product code: Code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2024-06-07
Decision date: 2024-12-20
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QOF

K261837 — FINDER Flu A&B/SARS-CoV-2 Test2026-09-11
K252932 — Fast PCR Mini Respiratory Panel2026-06-12
K252269 — FINDER Flu A&B/SARS-CoV-2 Test2026-03-30
K251742 — VELO Respiratory Test2026-02-13
K251978 — LIAISON NES FLU A/B, RSV & COVID-192025-12-23

Recalls naming K241652

K-number listed on FDA's recall record

Z-2274-2025 — 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 to users in quantities of 10 per kit. Used on the DASH instrument.Class II·Ongoing·Nuclein LLC·20250625

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K241652.

Data sourced from openFDA. This site is unofficial and independent of the FDA.