Alinity m STI Assay
Summary
Abbott Molecular, Inc. received 510(k) clearance for Alinity m STI Assay, a QEP device. Cleared on 2023-03-03.
Details
Source
510(k) Clearance
External ID
K222379
Action Date
2023-03-03
Status
Traditional
Category
device
Product Code
QEP
Product Description
Alinity m STI Assay. Product code: QEP.
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. Abbott Molecular, Inc. has received 9 total clearances in our database.
Abbott Molecular, Inc. has 39 FDA actions in our database, including 30 recalls and 9 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 Abbott Molecular, Inc. have FDA actions?
Abbott Molecular, Inc. has 39 FDA actions in our database, including 30 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K222379" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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