ConcizuTrace ELISA
Summary
Randox Laboratories, Ltd. received 510(k) clearance for ConcizuTrace ELISA, a SES device. Cleared on 2025-05-22.
Details
Source
510(k) Clearance
External ID
DEN240035
Action Date
2025-05-22
Status
Direct
Category
device
Product Code
SES
Product Description
ConcizuTrace ELISA. Product code: SES.
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. Randox Laboratories, Ltd. has received 2 total clearances in our database.
Randox Laboratories, Ltd. has 39 FDA actions in our database, including 37 recalls and 2 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 Randox Laboratories, Ltd. have FDA actions?
Randox Laboratories, Ltd. has 39 FDA actions in our database, including 37 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "DEN240035" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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