|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
super sani-cloth/ accu-chek inform ii system
|
ROCHE DIAGNOSTICS CORP.
|
K130138 |
03/15/2013
|
modification to accu-chek inform meter
|
ROCHE DIAGNOSTICS CORP.
|
K012210 |
08/09/2001
|
modification to accu-chek go system
|
ROCHE DIAGNOSTICS CORP.
|
K051592 |
09/02/2005
|
modification to accu-chek active system
|
ROCHE DIAGNOSTICS CORP.
|
K021448 |
06/03/2002
|
modification to accu-chek active system
|
ROCHE DIAGNOSTICS CORP.
|
K021827 |
07/03/2002
|
glucose test system
|
Roche Diagnostics
|
K113137 |
01/06/2012
|
accuchek instant plus dual testing system, accuchek instant plus cholesterol, accuchek instant plus glucocose
|
Roche Diagnostics
|
K051376 |
08/23/2005
|
accu-chek smart pix
|
ROCHE DIAGNOSTICS CORP.
|
K062395 |
05/09/2007
|
accu-chek performa system
|
ROCHE DIAGNOSTICS CORP.
|
K070585 |
05/25/2007
|
accu-chek performa blood glucose monitoring system
|
Roche Diagnostics
|
K133741 |
08/29/2014
|