ReliOn Premier BLU Blood Glucose Monitoring System
Summary
I-Sens, Inc. received 510(k) clearance for ReliOn Premier BLU Blood Glucose Monitoring System, a NBW device. Cleared on 2023-08-10.
Details
Source
510(k) Clearance
External ID
K230625
Action Date
2023-08-10
Status
Special
Category
device
Product Code
NBW
Product Description
ReliOn Premier BLU Blood Glucose Monitoring System. Product code: NBW.
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. I-Sens, Inc. has received 2 total clearances in our database.
I-Sens, Inc. has 2 FDA actions in our database, including 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 I-Sens, Inc. have FDA actions?
I-Sens, Inc. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K230625" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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