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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK030703/A003
Test Name YOUR 1ST CHOICE FOR VALUE! TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
Manufacturer NameHOME DIAGNOSTICS, INC.
Consumer Information Phone Number(800)342-7226
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date08/22/2003
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
Applicant
HOME DIAGNOSTICS, INC.
2400 N.W. 55TH CT.
FORT LAUDERDALE,  FL  33309
Applicant Contact KAREN DEVINCENT
Correspondent
HOME DIAGNOSTICS, INC.
2400 N.W. 55TH CT.
FORT LAUDERDALE,  FL  33309
Correspondent Contact KAREN DEVINCENT
Regulation Number862.1345
Classification Product Code
NBW  
Date Received03/06/2003
Decision Date 07/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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