Device Classification Name |
integrated continuous glucose monitoring system, factory calibrated
|
510(k) Number |
K233537 |
Device Name |
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System |
Applicant |
Abbott Diabetes Care Inc. |
1360 South Loop Road |
Alameda,
CA
94202
|
|
Applicant Contact |
Sapna Ghelani |
Correspondent |
Abbott Diabetes Care Inc. |
1360 South Loop Road |
Alameda,
CA
94202
|
|
Correspondent Contact |
Sapna Ghelani |
Regulation Number | 862.1355
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/03/2023 |
Decision Date | 04/23/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|