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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K062799
Device Name GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Apex BioTechnology Corp.
5182 W. 76th St.
Edina,  MN  55439
Applicant Contact BRUCE A MACFARLANE
Correspondent
Apex BioTechnology Corp.
5182 W. 76th St.
Edina,  MN  55439
Correspondent Contact BRUCE A MACFARLANE
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received09/19/2006
Decision Date 02/06/2007
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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