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FDA 510(k)

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

K-Number: K210943 · 2021-11-22

ApplicantAbbott Diabetes Care, Inc.
Decision Date2021-11-22
Product CodeQLG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) is a medical device manufactured by Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2021-11-22 under approval number K210943. The device is classified under product code QLG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)?

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) is a medical device that received FDA 510(k) clearance on 2021-11-22. It is manufactured by Abbott Diabetes Care, Inc.. The 510(k) number is K210943.

When was FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) approved by the FDA?

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) received FDA 510(k) clearance on 2021-11-22, under approval number K210943.

What company makes FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)?

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) is manufactured by Abbott Diabetes Care, Inc..

What is the FDA product code for FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)?

The FDA product code for FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) is QLG.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07599982 Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes RECRUITING NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41964171 Journal of diabetes science and technology (2026) PMID: 41760572 Trends in use of continuous glucose monitors among individuals with type 2 diabetes enrolled in Medicare Advantage (2021-2023). Journal of managed care & specialty pharmacy (2026)

Other Devices by Abbott Diabetes Care, Inc.

K153330FreeStyle Precision Neo H Blood Glucose Monitoring System K171941FreeStyle Precision Neo Blood Glucose Test Strips K193371FreeStyle Libre 2 Flash Glucose Monitoring System K211102FreeStyle Libre 2 Flash Glucose Monitoring System K201761FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) K213996FreeStyle Libre 3 Continuous Glucose Monitoring System

View all 14 devices →

Related Devices (Code: QLG)

K193371FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. K211102FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. K201761FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc. K202145Bigfoot Unity Diabetes Management SystemBigfoot Biomedical, Inc. K213996FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc. K212132FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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