FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

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 (with Freestyle Libre 2 App).

Pre-market Notification Details

Device IDK201761
510k NumberK201761
Device Name:FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
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
ContactOno Bacani
CorrespondentOno Bacani
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 Received2020-06-29
Decision Date2021-07-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00357599810009 K201761 000

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