Source document or public record
FDA 510(k) K210943 — FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
FDA 510(k) index record K210943. Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App). Applicant as listed: Abbott Diabetes Care, Inc.. Decision date: 2021-11-22.
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"device_name": "FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K210943.
Device name: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App). Applicant as listed: Abbott Diabetes Care, Inc..
Decision date: 2021-11-22. Decision wording: Substantially Equivalent.
Product code: QLG. Regulation: 21 CFR 862.1355. Medical specialty: Clinical Chemistry.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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