FreeStyle Libre 3 Continuous Glucose Monitoring System

Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

Abbott Diabetes Care Inc.

The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Freestyle Libre 3 Continuous Glucose Monitoring System.

Pre-market Notification Details

Device IDK212132
510k NumberK212132
Device Name:FreeStyle Libre 3 Continuous Glucose Monitoring System
ClassificationIntegrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Applicant Abbott Diabetes Care Inc. 1360 South Loop Road Alameda,  CA  94502
ContactNaveen Thuramalla
CorrespondentNaveen Thuramalla
Abbott Diabetes Care Inc. 1360 South Loop Road Alameda,  CA  94502
Product CodeQLG  
CFR Regulation Number862.1355 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-08
Decision Date2022-05-26

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