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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 K060793
Device Name ELEMENT BLOOD GLUCOSE TEST SYSTEM
Original Applicant
HOME DIAGNOSTICS, INC.
2400 n.w. 55th ct.
fort lauderdale,  FL  33309
Original Contact karen de vincent
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received03/23/2006
Decision Date 07/25/2006
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
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