Abbott Diabetes Care - FDA 510(k) Cleared Devices

Abbott Diabetes Care, develops continuous glucose monitoring and blood glucose management systems. The company operates with a manufacturing facility in Alameda, US, and serves patients managing diabetes globally through innovative Chemistry devices.

Abbott Diabetes Care has received 2 FDA 510(k) clearances from 2 total submissions since 2013. The company specializes exclusively in Chemistry devices for glucose and ketone monitoring. Its latest clearance in 2024 reflects continued regulatory activity and product innovation in diabetes care technology.

The company's portfolio includes continuous glucose monitoring systems and blood glucose monitoring platforms designed for real-time diabetes management. These devices support both routine monitoring and advanced metabolic assessment for patients with diabetes.

Explore the complete clearance record, including device names, product codes, and approval dates, to review Abbott Diabetes Care's regulatory submissions and cleared devices.