Documento fuente o registro público
FDA 510(k) K222447 — FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System
FDA 510(k) index record K222447. Device: FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System. Applicant as listed: Abbott Diabetes Care, Inc.. Decision date: 2023-03-03.
Fuente
"device_name": "FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-29
professional use
FDA 510(k) public index record K222447.
Device name: FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System. Applicant as listed: Abbott Diabetes Care, Inc..
Decision date: 2023-03-03. Decision wording: Substantially Equivalent.
Product code: QBJ. 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.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.