510(k) K222447— FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System
Substantially EquivalentAbbott Diabetes Care, Inc.
Clearance details
- Applicant
- Abbott Diabetes Care, Inc.
- Product code
- Code QBJ
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
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.