Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
Summary
Roche Diabetes Care GmbH received 510(k) clearance for Accu-Chek Guide Solo diabetes manager blood glucose monitoring system, a NBW device. Cleared on 2023-08-10.
Details
Source
510(k) Clearance
External ID
K213131
Action Date
2023-08-10
Status
Traditional
Category
device
Product Code
NBW
Product Description
Accu-Chek Guide Solo diabetes manager 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. Roche Diabetes Care GmbH has received 2 total clearances in our database.
Roche Diabetes Care GmbH 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 Roche Diabetes Care GmbH have FDA actions?
Roche Diabetes Care GmbH 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 "K213131" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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