AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS

Glucose Oxidase, Glucose

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 And Test Strips.

Pre-market Notification Details

Device IDK102037
510k NumberK102037
Device Name:AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS
ClassificationGlucose Oxidase, Glucose
Applicant APEX BIOTECHNOLOGY CORP. NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK Hsinchu,  TW 30078
ContactHsue-mei Lee
CorrespondentHsue-mei Lee
APEX BIOTECHNOLOGY CORP. NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK Hsinchu,  TW 30078
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-19
Decision Date2010-08-13
Summary:summary

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