|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
prestige iq blood glucose test system, model 507400, 537600, 550600, 561700, 563700
|
HOME DIAGNOSTICS, INC.
|
K010403 |
03/26/2001
|
truetrack smart system blood glucose meter and true track smart system blood glucose test strips
|
HOME DIAGNOSTICS, INC.
|
K030703 |
07/11/2003
|
truetrack smart system blood glucose meter, blood glucose test strips, and glucose control solutions (low and high)
|
HOME DIAGNOSTICS, INC.
|
K032657 |
03/24/2004
|
modification to truetrack smart system blood glucose meter, test strips and glucose control
|
HOME DIAGNOSTICS, INC.
|
K040670 |
03/25/2004
|
trackease smart system blood glucose system
|
HOME DIAGNOSTICS, INC.
|
K042080 |
08/19/2004
|
sidekick blood glucose test system
|
HOME DIAGNOSTICS, INC.
|
K051147 |
07/12/2005
|
element blood glucose test system
|
HOME DIAGNOSTICS, INC.
|
K060793 |
07/25/2006
|
trackrecord data management software
|
HOME DIAGNOSTICS, INC.
|
K070593 |
05/07/2007
|
true2go blood glucose system, model f4h01-81
|
HOME DIAGNOSTICS, INC.
|
K080710 |
08/13/2008
|
trueresult blood glucose system e4h01-81
|
HOME DIAGNOSTICS, INC.
|
K080641 |
08/19/2008
|
|