GlucoSure Link Blood Glucose Monitoring System

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 Glucosure Link Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK212140
510k NumberK212140
Device Name:GlucoSure Link Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant Apex Biotechnology Corp. No. 7, Li-Hsin Rd. V, Hsinchu Science Park Hsinchu,  TW 30078
ContactLisa Liu
CorrespondentLisa Liu
Apex Biotechnology Corp. No. 7, Li-Hsin Rd. V, Hsinchu Science Park Hsinchu,  TW 30078
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-08
Decision Date2022-08-25

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