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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 K062538
Device Name EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Diacare Corp.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact SID MATHUR
Correspondent
Diacare Corp.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact SID MATHUR
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received08/29/2006
Decision Date 04/30/2007
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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