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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 K153286
Device Name iHealth Align Gluco-Monitoring system
Applicant
Andon Health Co, Ltd.
# 3 Jimping St., Ya'Am Rd., Nankai District
Tianjin,  CN 300190
Applicant Contact Yi Liu
Correspondent
Andon Health Co, Ltd.
# 3 Jimping St., Ya'Am Rd., Nankai District
Tianjin,  CN 300190
Correspondent Contact Yi Liu
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received11/12/2015
Decision Date 08/19/2016
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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