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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK133045
Test Name Infopia Element Lite Blood Glucose Monitoring System  
Manufacturer NameInfopia Co, Ltd.
Consumer Information Phone Number(888)446-3246
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date04/14/2014
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K133045
Device Name ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Infopia Co, Ltd.
891 Hogye-Dong
Dongan-Gu
Anyang, Kyunggi,  KR 431-080
Applicant Contact SeonMi Shin
Correspondent
LK Consulting Group USA, Inc.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Correspondent Contact Priscilla Chung
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received09/27/2013
Decision Date 04/10/2014
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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