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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 K120423
Device Name BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650
Original Applicant
BIONIME CORPORATION
2700 lapaz road
suite 266b
mission viejo,  CA  92691
Original Contact feng-yu lee
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received02/13/2012
Decision Date 08/03/2012
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
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