FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System— 510(k) K222447
Substantially EquivalentAbbott Diabetes Care, Inc.
FDA 510(k) clearance K222447 for FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System, Substantially Equivalent on 2023-03-03. Applicant: Abbott Diabetes Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Diabetes Care, Inc.
- Product code
- Code QBJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1355
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
Recent devices under product code QBJ
view all- K261402 — Dexcom G7 Continuous Glucose Monitoring System; Dexcom G7 15 Day Continuous Glucose Monitoring System
- K253737 — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K253710 — Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K243214 — Dexcom G7 15 Day Continuous Glucose Monitoring System
- K233537 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
More clearances from Abbott Diabetes Care, Inc.
view all- K223435 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
- K223537 — FreeStyle Libre 2 System, FreeStyle Libre 3 System
- K212132 — FreeStyle Libre 3 Continuous Glucose Monitoring System
- K213996 — FreeStyle Libre 3 Continuous Glucose Monitoring System
- K210943 — FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
Adverse events under product code QBJ
product code QBJ- Death
- 180
- Injury
- 31,825
- Malfunction
- 1,792,244
- Other
- 36
- Total
- 1,824,285
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.