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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name single (specified) analyte controls (assayed and unassayed)
510(k) Number K042080
Device Name TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
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 Number862.1660
Classification Product Code
JJX  
Subsequent Product Code
NBW  
Date Received08/03/2004
Decision Date 08/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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