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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK150274
Test Name Infopia Co., Ltd. GDH Professional LED Blood Glucose Monitoring System  
Manufacturer NameInfopia Co, Ltd.
Consumer Information Phone Number(855)464-6283
Test TypeGlucose monitoring devices (prescription use only)
Effective Date09/02/2015
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K150274
Device Name GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System
Applicant
Infopia Co, Ltd.
132, Anyangcheondong-Ro
Dongan-Gu
Anyang,  KR 431-836
Applicant Contact NA YUN KIM
Correspondent
LK Consulting Group USA, Inc.
2651 E Chapman Ave., Suite 110
Fullerton,  CA  92833
Correspondent Contact PRISCILLA CHUNG
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received02/04/2015
Decision Date 08/26/2015
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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