|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
precision xceed pro blood glucose and b-ketone monitoring system with models bgms:70900-03, 70090-02, g3ch strips
|
ABBOTT DIABETES CARE INC.
|
K080960 |
09/05/2008
|
relion ultima advance blood glucose monitoring system models, bgms 71030-01 strips: 7103-01 (20 count)
|
ABBOTT DIABETES CARE INC.
|
K081975 |
11/26/2008
|
relion ultima blood glucose monitoring system, models 70055-50, strips (20 count): 70973-01
|
ABBOTT DIABETES CARE INC.
|
K083223 |
04/16/2009
|
freestyle lite blood glucose monitoring system and freestyle freedom lite blood glucose monitoring system
|
ABBOTT DIABETES CARE INC.
|
K092602 |
05/14/2010
|
freestyle blood glucose test strips, models 100-count: 12401-01, 12101-21, 12101-22, 12101-23
|
ABBOTT DIABETES CARE INC.
|
K092638 |
06/15/2010
|
freestyle insulinx blood glucose monitoring system
|
ABBOTT DIABETES CARE INC.
|
K120568 |
03/29/2012
|
freestyle precision pro blood glucose and b-ketone monitoring system
|
ABBOTT DIABETES CARE INC.
|
K132511 |
12/24/2013
|
freestyle precision neo blood glucose: monitoring system, test strips (50ct), test strips (100ct)
|
ABBOTT DIABETES CARE INC.
|
K140371 |
09/30/2014
|
freestyle precision neo blood glucose monitoring system
|
ABBOTT DIABETES CARE INC
|
K142928 |
09/30/2015
|
freestyle precision neo h blood glucose monitoring system
|
Abbott Diabetes Care Inc.
|
K153330 |
02/19/2016
|