|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
freestyle precision neo blood glucose test strips
|
Abbott Diabetes Care Inc.
|
K171941 |
09/27/2017
|
freestyle libre 2 flash glucose monitoring system
|
Abbott Diabetes Care Inc.
|
K193371 |
06/12/2020
|
freestyle libre 2 flash glucose monitoring system (with freestyle libre 2 app)
|
Abbott Diabetes Care Inc.
|
K201761 |
07/30/2021
|
freestyle libre 2 flash glucose monitoring system (with freestyle libre 2 app)
|
Abbott Diabetes Care Inc.
|
K210943 |
11/22/2021
|
freestyle libre 2 flash glucose monitoring system; freestyle libre 3 continuous glucose monitoring system
|
Abbott Diabetes Care Inc.
|
K222447 |
03/03/2023
|
freestyle libre 3 continuous glucose monitoring system; freestyle libre 2 flash glucose monitoring system
|
Abbott Diabetes Care Inc.
|
K223435 |
04/13/2023
|
freestyle libre 3 continuous glucose monitoring system; freestyle libre 2 flash glucose monitoring system
|
Abbott Diabetes Care Inc.
|
K233537 |
04/23/2024
|