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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK133790
Test Name Andon iHealth Align Mini Gluco-Monitoring System  
Manufacturer NameAndon Health Co, Ltd.
Consumer Information Phone Number(855)816-7705
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date05/27/2014
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K133790
Device Name IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
Applicant
Andon Health Co, Ltd.
#3 Jinping St., Yaan Rd., Nankai District
Tianjin,  CN 300190
Applicant Contact YI LIU
Correspondent
Andon Health Co, Ltd.
#3 Jinping St., Yaan Rd., Nankai District
Tianjin,  CN 300190
Correspondent Contact YI LIU
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JQP  
Date Received12/09/2013
Decision Date 05/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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