Device Classification Name |
Integrated Continuous Glucose Monitoring System, Factory Calibrated
|
510(k) Number |
K222447 |
Device Name |
FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System |
Applicant |
Abbott Diabetes Care Inc. |
1360 South Loop Road |
Alameda,
CA
94502
|
|
Applicant Contact |
Catherine Yang |
Correspondent |
Abbott Diabetes Care Inc. |
1360 South Loop Road |
Alameda,
CA
94502
|
|
Correspondent Contact |
Catherine Yang |
Regulation Number | 862.1355
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/15/2022 |
Decision Date | 03/03/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT05251116
|
Reviewed by Third Party |
No
|
Combination Product |
No
|