FDA 510(k)

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

K-Number: K210943 · 2021-11-22

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 the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2021-11-22 under 510(k) 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. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K210943.

When did FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) receive FDA 510(k) clearance?

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

Who is the listed applicant for FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)?

The FDA 510(k) record lists Abbott Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05944432CGM Use in Adults With Type 2 Diabetes on Basal InsulinACTIVE_NOT_RECRUITING NCT07739342Evaluating the Occurrence of DKA in People With Type I DiabetesNOT_YET_RECRUITING NCT04959552FSL2 Post Approval Study for Pediatric and Young Adults PatientsACTIVE_NOT_RECRUITING NCT05676593Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic PatientsTERMINATED NCT05720377Evaluation of Exercise Application Technology in AdolescentsWITHDRAWN NCT06083038Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating AlpelisibCOMPLETED

Other records listing Abbott Diabetes Care, Inc. as applicant

PMA P160030Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated PMA P150021Sensor, glucose, invasive K233861Libre Rio Continuous Glucose Monitoring System K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System K223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System K222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System

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Related Devices (Code: QLG)

K222280Bigfoot Unity® Diabetes Management SystemBigfoot Biomedical, Inc.K223537FreeStyle Libre 2 System, FreeStyle Libre 3 SystemAbbott Diabetes Care, Inc.K213996FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc.K212132FreeStyle Libre 3 Continuous 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.

Official Source

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