FreeStyle Libre 2 Flash Glucose Monitoring System
K-Number: K193371 · 2020-06-12
ApplicantAbbott Diabetes Care, Inc.
Decision Date2020-06-12
Product CodeQLG
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
FreeStyle Libre 2 Flash Glucose Monitoring System is a medical device manufactured by Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2020-06-12 under approval number K193371. 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?
FreeStyle Libre 2 Flash Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2020-06-12. It is manufactured by Abbott Diabetes Care, Inc.. The 510(k) number is K193371.
When was FreeStyle Libre 2 Flash Glucose Monitoring System approved by the FDA?
FreeStyle Libre 2 Flash Glucose Monitoring System received FDA 510(k) clearance on 2020-06-12, under approval number K193371.
What company makes FreeStyle Libre 2 Flash Glucose Monitoring System?
FreeStyle Libre 2 Flash Glucose Monitoring System is manufactured by Abbott Diabetes Care, Inc..
What is the FDA product code for FreeStyle Libre 2 Flash Glucose Monitoring System?
The FDA product code for FreeStyle Libre 2 Flash Glucose Monitoring System is QLG.
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Other Devices by Abbott Diabetes Care, Inc.
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Official Source
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