FreeStyle Libre 2 Flash 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 2 Flash Glucose Monitoring System.

Pre-market Notification Details

Device IDK193371
510k NumberK193371
Device Name:FreeStyle Libre 2 Flash 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 Received2019-12-05
Decision Date2020-06-12

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