LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit
Summary
Diasorin Molecular, LLC received 510(k) clearance for LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit, a PGX device. Cleared on 2026-06-15.
Details
Source
510(k) Clearance
External ID
K260333
Action Date
2026-06-15
Status
Dual Track
Category
device
Product Code
PGX
Product Description
LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit. Product code: PGX.
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. Diasorin Molecular, LLC has received 6 total clearances in our database.
Diasorin Molecular, LLC has 11 FDA actions in our database, including 5 recalls and 6 clearances.
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 Diasorin Molecular, LLC have FDA actions?
Diasorin Molecular, LLC has 11 FDA actions in our database, including 5 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K260333" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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