ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM

System, Test, Blood Glucose, Over The Counter

INFOPIA CO., LTD

The following data is part of a premarket notification filed by Infopia Co., Ltd with the FDA for Element Plus Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK103021
510k NumberK103021
Device Name:ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant INFOPIA CO., LTD 951 STARBUCK ST. UNIT J Fullerton,  CA  92833
ContactPriscilla Chung
CorrespondentPriscilla Chung
INFOPIA CO., LTD 951 STARBUCK ST. UNIT J Fullerton,  CA  92833
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-12
Decision Date2011-11-04
Summary:summary

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