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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 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 2023-02-21 under 510(k) 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. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K223537.

When did FreeStyle Libre 2 System, FreeStyle Libre 3 System receive FDA 510(k) clearance?

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

Who is the listed applicant for FreeStyle Libre 2 System, FreeStyle Libre 3 System?

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 System, FreeStyle Libre 3 System?

The FDA product code for FreeStyle Libre 2 System, FreeStyle Libre 3 System 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_RECRUITINGNCT07739342Evaluating the Occurrence of DKA in People With Type I DiabetesNOT_YET_RECRUITING

Other records listing Abbott Diabetes Care, Inc. as applicant

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.

PMA P160030Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiatedPMA P150021Sensor, glucose, invasiveK233861Libre Rio Continuous Glucose Monitoring SystemK233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemK223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemK222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System

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Related Devices (Code: QLG)

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.

K222280Bigfoot 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.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.

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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