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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K030703
Device Name TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS
Original Applicant
HOME DIAGNOSTICS, INC.
2400 n.w. 55th ct.
fort lauderdale,  FL  33309
Original Contact karen devincent
Regulation Number862.1345
Classification Product Code
NBW  
Date Received03/06/2003
Decision Date 07/11/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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