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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 11 Results
ProductCode: NBW Applicant: HOME DIAGNOSTICS, INC Decision Date To: 07/30/2014
 
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truebalance blood glucose system HOME DIAGNOSTICS, INC. K090495 03/27/2009
trueresult blood glucose system e4h01-81 HOME DIAGNOSTICS, INC. K080641 08/19/2008
true2go blood glucose system, model f4h01-81 HOME DIAGNOSTICS, INC. K080710 08/13/2008
trackrecord data management software HOME DIAGNOSTICS, INC. K070593 05/07/2007
element blood glucose test system HOME DIAGNOSTICS, INC. K060793 07/25/2006
sidekick blood glucose test system HOME DIAGNOSTICS, INC. K051147 07/12/2005
trackease smart system blood glucose system HOME DIAGNOSTICS, INC. K042080 08/19/2004
modification to truetrack smart system blood glucose meter, test strips and glucose control HOME DIAGNOSTICS, INC. K040670 03/25/2004
truetrack smart system blood glucose meter, blood glucose test strips, and glucose control solutions (low and high) HOME DIAGNOSTICS, INC. K032657 03/24/2004
truetrack smart system blood glucose meter and true track smart system blood glucose test strips HOME DIAGNOSTICS, INC. K030703 07/11/2003
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