Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System

K-Number: K223435 · 2023-04-13

ApplicantAbbott Diabetes Care, Inc.
Decision Date2023-04-13
Product CodeQBJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring 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 2023-04-13 under 510(k) number K223435. The device is classified under product code QBJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System?

FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K223435.

When did FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System receive FDA 510(k) clearance?

FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System received FDA 510(k) clearance on 2023-04-13, under 510(k) number K223435.

Who is the listed applicant for FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring 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 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System?

The FDA product code for FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System is QBJ.

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_RECRUITINGNCT04959552FSL2 Post Approval Study for Pediatric and Young Adults PatientsACTIVE_NOT_RECRUITINGNCT05676593Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic PatientsTERMINATEDNCT05720377Evaluation of Exercise Application Technology in AdolescentsWITHDRAWNNCT06083038Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating AlpelisibCOMPLETED

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 SystemK222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring SystemK223537FreeStyle Libre 2 System, FreeStyle Libre 3 System

View all 15 devices →

Related Devices (Code: QBJ)

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.

K261402Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring SystemDexcom, Inc.K253737Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.K253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.K243214Dexcom G7 15 Day Continuous Glucose Monitoring SystemDexcom, Inc.K240902Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc.K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash 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.

↑