Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips

System, Test, Blood Glucose, Over The Counter

APEX BIOTECHNOLOGY CORP.

The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Autosure Voice Ii Blood Glucose Monitoring System, Autosure Voice Ii Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips.

Pre-market Notification Details

Device IDK150396
510k NumberK150396
Device Name:Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant APEX BIOTECHNOLOGY CORP. NO. 7 LI-HSIN ROAD V, HSINCHU SCIENCE PARK Hsinchu,  CN 30078
ContactHsue-mei Lee
CorrespondentHsue-mei Lee
APEX BIOTECHNOLOGY CORP. NO. 7 LI-HSIN ROAD V, HSINCHU SCIENCE PARK Hsinchu,  CN 30078
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-18
Decision Date2015-10-14
Summary:summary

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