AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM

System, Test, Blood Glucose, Over The Counter

APEX BIO TECHNOLOGY CORP

The following data is part of a premarket notification filed by Apex Bio Technology Corp with the FDA for Autosure Voice 3 Plus Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK120649
510k NumberK120649
Device Name:AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant APEX BIO TECHNOLOGY CORP NO. 7, LI-HSIN ROAD V HSINCHU SCIENCE PARK Hsinchu,  TW 30078
ContactLisa Liu
CorrespondentLisa Liu
APEX BIO TECHNOLOGY CORP NO. 7, LI-HSIN ROAD V HSINCHU SCIENCE PARK Hsinchu,  TW 30078
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-02
Decision Date2012-07-06
Summary:summary

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