|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
glooko logbook charts
|
GLOOKO, INC.
|
K122142 |
12/21/2012
|
nova one blood glucose monitor
|
NOVA BIOMEDICAL CORPORATION
|
K122435 |
12/20/2012
|
on call vivid blood glucose monitoring system
|
ACON LABORATORIES, INC.
|
K123010 |
12/14/2012
|
da01 blood glucose monitoring system
|
DELBIO INCORPORATION
|
K120866 |
12/11/2012
|
omnipod insulin managment system
|
INSULET CORPORATION
|
K122953 |
12/07/2012
|
blood glucose monitoring system
|
ANDON MEDICAL CO., LTD
|
K120813 |
12/07/2012
|
genstrip test strip model 100-201
|
SHASTA TECHNOLOGIES, LLC
|
K103542 |
11/30/2012
|
acon on call vivid pal blood glucose monitoring system
|
ACON LABORATORIES, INC.
|
K122110 |
11/21/2012
|
accu-chek inform ii blood glucose monitoring system
|
Roche Diagnostics
|
K121679 |
10/11/2012
|
genesis health technologies blood glucose monitoring system
|
TaiDoc Technology Corporation
|
K121224 |
09/19/2012
|
test, blood glucose system
|
HMD BIOMEDICAL, INC.
|
K120064 |
09/05/2012
|
auto-chek blood glucose monitoring system, meter, test strip. auto-check control solution
|
i-SENS, Inc.
|
K121654 |
09/05/2012
|
tysonbio md100 blood glucse monitoring ,tysonbio md100 pro blood glucise monitoring system
|
TYSON BIORESEARCH, INC.
|
K112916 |
08/21/2012
|
clever choice
|
SIMPLE DIAGNOSTICS, INC.
|
K120921 |
08/21/2012
|
connected care clinical application
|
WATERMARK MEDICAL INC
|
K120320 |
08/14/2012
|
bioland g-423 glood glucose monitoring system
|
TaiDoc Technology Corporation
|
K113077 |
08/03/2012
|
bionime rightest blood glucose monitoring system, model gm650
|
BIONIME CORPORATION
|
K120423 |
08/03/2012
|
gl goodlife series blood glucose monitoring sysmtem
|
HMD BIOMEDICAL, INC.
|
K113307 |
07/27/2012
|
contour next blood glucose meter
|
BAYER HEALTHCARE LLC
|
K121190 |
07/26/2012
|
connected care mobile application
|
WATERMARK MEDICAL
|
K120325 |
07/18/2012
|
accu-check combo system
|
Roche Diagnostics
|
K111353 |
07/17/2012
|
vignet telehealth manager
|
VIGNET INC.
|
K113446 |
07/16/2012
|
healthpro blood glucose monitoring system
|
INFOPIA CO., LTD
|
K113192 |
07/13/2012
|
caresens n voice blood glucose monitoring system
|
i-SENS, Inc.
|
K121133 |
07/10/2012
|
autosure voice 3 plus blood glucose monitoring system
|
APEX BIO TECHNOLOGY CORP
|
K120649 |
07/06/2012
|
constant care lilah home health monitoring system
|
CONSTANT CARE, LLC
|
K120941 |
07/03/2012
|
contour next usb blood glucose monitoring system
|
BAYER HEALTHCARE
|
K121087 |
06/28/2012
|
caresens n mini blood glucose monitoring system, mini blood glucose meter, blood glucose test strip, control solution
|
i-SENS, Inc.
|
K120759 |
06/05/2012
|
hl 568 self monitoring blood glucose system, hl 568ba self-moniroting blood glucose system
|
HEALTH & LIFE CO., LTD.
|
K110074 |
05/25/2012
|
td-4268 blood glucose monitoring system td-4268 multi blood glucose monitoring system
|
TaiDoc Technology Corporation
|
K120042 |
05/22/2012
|
easymax mu self monitoring blood glucose system, easymax mu pro self monitoring blood glucose system
|
EPS BIO TECHNOLOGY CORP.
|
K121207 |
05/18/2012
|
advocate redi-code+bmb-ea001s blood glucose monitoring system
|
BROADMASTER BIOTECH CORPERATION
|
K120183 |
05/11/2012
|
element blood glucose monitoring system
|
INFOPIA CO., LTD
|
K113670 |
05/08/2012
|
caresens n pop blood glucose monitoring system caresens n pop blood glucose meter caresens n blood glucose test strip ca
|
i-SENS, Inc.
|
K120351 |
05/03/2012
|
ap-3000 blood glucose monitoring system, major glucose control solution
|
BESTGEN BIOTECH CORP.
|
K103230 |
04/24/2012
|
on call chosen lancing device
|
ACON LABORATORIES, INC.
|
K113332 |
04/18/2012
|
u-right td-4280 blood glucose monitoring system
|
TaiDoc Technology Corporation
|
K113768 |
04/12/2012
|
on call vivid blood glucose monitoring systems
|
ACON LABORATORIES, INC.
|
K112653 |
04/09/2012
|
meg-2b blood glucose monitoring system, pro blood glucose monitoring system, blood glucose test strips, glucose control
|
APEX BIOTECHNOLOGY CORP.
|
K120448 |
04/06/2012
|
rightest blood glucose monitoring system gm700
|
BIONIME CORPORATION
|
K110737 |
03/29/2012
|
freestyle insulinx blood glucose monitoring system
|
ABBOTT DIABETES CARE INC.
|
K120568 |
03/29/2012
|
contour link blood glucose meter, contour blood glucose test strips, contour control solution (high, normal, low)
|
BAYER HEALTHCARE, LLC
|
K110587 |
03/28/2012
|
em50 self monitoring blood glucose system
|
EPS BIO TECHNOLOGY CORP.
|
K113243 |
03/28/2012
|
contour next link wireless blood glucose meter
|
BAYER HEALTHCARE
|
K110894 |
03/28/2012
|
gal-1e blood glucose monitoring system gal-1e blood glucose test strips gal-1e multi blood glucose monitoring system gal
|
APEX BIOTECHNOLOGY CORP.
|
K113547 |
03/28/2012
|
diatrue plus blood glucose monitoring system; diatrue plus blood glucose test strip; diatrue glucose control solution
|
DELBIO INCORPORATION
|
K103329 |
03/13/2012
|
ap-2000, ap-2010, and ap-2020 blood glucose monitoring system
|
BESTGEN BIOTECH CORP.
|
K103116 |
03/13/2012
|
nova max one blood glucose monitor, nova max one blood glucose test strips
|
NOVA BIOMEDICAL CORPORATION
|
K112638 |
03/09/2012
|
contour (r) next blood glucose monitoring system
|
BAYER HEALTHCARE
|
K111268 |
03/06/2012
|
medisign blood glucose monitoring system
|
TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
|
K111456 |
02/28/2012
|
bionime diabetes management system vi.0
|
BIONIME CORPORATION
|
K113007 |
02/27/2012
|
freestyle insulinx blood glucose monitoring systems
|
ABBOTT LABORATORIES
|
K111874 |
02/16/2012
|
ap-1010 and ap-1020 blood glucose monitoring system, major glucose control solution
|
BESTGEN BIOTECH CORP.
|
K103044 |
02/10/2012
|
diacheck smart/superior blood glucose monitoring system
|
DELBIO INCORPORATION
|
K113343 |
02/08/2012
|
fora diamond prima blood glucose monitoring system, fora diamond mini blood glucose monitoring system
|
TaiDoc Technology Corporation
|
K111890 |
02/06/2012
|
microdot & microdot xtra
|
CAMBRIDGE SENSORS LIMITED
|
K102383 |
01/27/2012
|
gal-1a blood glucose monitoring system
|
APEX BIOTECHNOLOGY CORP.
|
K113208 |
01/26/2012
|
ag-608n blood glucose monitoring system
|
ANDON MEDICAL CO., LTD.
|
K110017 |
01/18/2012
|
autosure voice ii plus, autosure plus blood glucose test strips,contrex plus iii
|
APEX BIOTECHNOLOGY CORP.
|
K113098 |
01/17/2012
|
ap-1000 blood glucose monitoring system, model ap-1000, major glucose control solution
|
BESTGEN BIOTECH CORP.
|
K100437 |
01/12/2012
|
glucose test system
|
Roche Diagnostics
|
K113137 |
01/06/2012
|