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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 K133522
Device Name RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM
Applicant
Bionime Coporation
2700 La Paz Rd.
Suite 266b
Mission Viejo,  CA  92691
Applicant Contact Feng-Yu Lee
Correspondent
Bionime Coporation
2700 La Paz Rd.
Suite 266b
Mission Viejo,  CA  92691
Correspondent Contact Feng-Yu Lee
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JQP   LFR  
Date Received11/15/2013
Decision Date 04/17/2014
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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