ARCHITECT iGentamicin
Summary
Abbott Laboratories received 510(k) clearance for ARCHITECT iGentamicin, a LCD device. Cleared on 2025-07-09.
Details
Source
510(k) Clearance
External ID
K243500
Action Date
2025-07-09
Status
Special
Category
device
Product Code
LCD
Product Description
ARCHITECT iGentamicin. Product code: LCD.
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 413 device clearances issued this month. Abbott Laboratories has received 15 total clearances in our database.
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 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 Laboratories have FDA actions?
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K243500" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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