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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 K052818
Device Name EZ SMART-168 GLUCOSE MONITORING SYSTEM
Applicant
Tyson Bioresearch, Inc.
3000 K St. NW
Suite 500
Washington,  DC  20007
Applicant Contact DAVID ROSEN
Correspondent
Tyson Bioresearch, Inc.
3000 K St. NW
Suite 500
Washington,  DC  20007
Correspondent Contact DAVID ROSEN
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received10/04/2005
Decision Date 06/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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