Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer
Summary
Abbott Diagnostics Technologies AS received 510(k) clearance for Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer, a LCP device. Cleared on 2023-09-27.
Details
Source
510(k) Clearance
External ID
K214117
Action Date
2023-09-27
Status
Dual Track
Category
device
Product Code
LCP
Product Description
Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer. Product code: LCP.
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.
Abbott Diagnostics Technologies AS 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 Abbott Diagnostics Technologies AS have FDA actions?
Abbott Diagnostics Technologies AS 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 "K214117" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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