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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK043340
Test Name VIP Diagnostics LLC EZ Smart Blood Glucose Monitoring System  
Manufacturer NameVip Diagnostics, LLC
Consumer Information Phone Number(800)290-2060
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date06/03/2005
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K043340
Device Name EZ SMART
Applicant
Vip Diagnostics, LLC
1200 19th St. NW
Washington,  DC  20036
Applicant Contact DAVID L ROSEN
Correspondent
Vip Diagnostics, LLC
1200 19th St. NW
Washington,  DC  20036
Correspondent Contact DAVID L ROSEN
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received12/03/2004
Decision Date 06/02/2005
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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