DASH® SARS-CoV-2 & Flu A/B Test
Summary
Nuclein, LLC received 510(k) clearance for DASH® SARS-CoV-2 & Flu A/B Test, a QOF device. Cleared on 2024-12-20.
Details
Source
510(k) Clearance
External ID
K241652
Action Date
2024-12-20
Status
Dual Track
Category
device
Product Code
QOF
Product Description
DASH® SARS-CoV-2 & Flu A/B Test. Product code: QOF.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Nuclein, LLC has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Nuclein, LLC have FDA actions?
Nuclein, LLC has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K241652" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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