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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 K150833
Device Name iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System
Applicant
ANDON HEALTH CO.,LTD
NO 3, JINPING RD, YA AN ST
NANKAI DISTRICT
TIANJIN,  CN 300193
Applicant Contact Yi Liu
Correspondent
ANDON HEALTH CO.,LTD
NO 3, JINPING RD, YA AN ST
NANKAI DISTRICT
TIANJIN,  CN 300193
Correspondent Contact Yi Liu
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JQP  
Date Received03/30/2015
Decision Date 12/04/2015
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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