MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL

Glucose Oxidase, Glucose

APEX BIOTECHNOLOGY CORP.

The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Meg-2b Blood Glucose Monitoring System, Pro Blood Glucose Monitoring System, Blood Glucose Test Strips, Glucose Control.

Pre-market Notification Details

Device IDK120448
510k NumberK120448
Device Name:MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
ClassificationGlucose Oxidase, Glucose
Applicant APEX BIOTECHNOLOGY CORP. NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK Hsinchu,  TW 30078
ContactLisa Liu
CorrespondentLisa Liu
APEX BIOTECHNOLOGY CORP. NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK Hsinchu,  TW 30078
Product CodeCGA  
Subsequent Product CodeJJX
Subsequent Product CodeNBW
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-14
Decision Date2012-04-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40884389831206 K120448 000
30888277365944 K120448 000

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