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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 K110737
Device Name RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700
Applicant
Bionime Corporation
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact JIGAR SHAH
Correspondent
Bionime Corporation
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact JIGAR SHAH
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received03/16/2011
Decision Date 03/29/2012
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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