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FDA 510(k)

FreeStyle Libre 2 System, FreeStyle Libre 3 System

K-Number: K223537 · 2023-02-21

ApplicantAbbott Diabetes Care, Inc.
Decision Date2023-02-21
Product CodeQLG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FreeStyle Libre 2 System, FreeStyle Libre 3 System is a medical device manufactured by Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2023-02-21 under approval number K223537. 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 System, FreeStyle Libre 3 System?

FreeStyle Libre 2 System, FreeStyle Libre 3 System is a medical device that received FDA 510(k) clearance on 2023-02-21. It is manufactured by Abbott Diabetes Care, Inc.. The 510(k) number is K223537.

When was FreeStyle Libre 2 System, FreeStyle Libre 3 System approved by the FDA?

FreeStyle Libre 2 System, FreeStyle Libre 3 System received FDA 510(k) clearance on 2023-02-21, under approval number K223537.

What company makes FreeStyle Libre 2 System, FreeStyle Libre 3 System?

FreeStyle Libre 2 System, FreeStyle Libre 3 System is manufactured by Abbott Diabetes Care, Inc..

What is the FDA product code for FreeStyle Libre 2 System, FreeStyle Libre 3 System?

The FDA product code for FreeStyle Libre 2 System, FreeStyle Libre 3 System is QLG.

Related Clinical Trials

NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07607015 CGM Experience, Preferences & Blood Glucose Parameters NOT_YET_RECRUITING NCT05944432 CGM Use in Adults With Type 2 Diabetes on Basal Insulin ACTIVE_NOT_RECRUITING NCT05720377 Evaluation of Exercise Application Technology in Adolescents WITHDRAWN NCT06083038 Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib COMPLETED

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 K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) K211102FreeStyle Libre 2 Flash Glucose Monitoring System K201761FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

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Related Devices (Code: QLG)

K193371FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott 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.

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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