GlucoSure HT Plus 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 Ht Plus Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK202885
510k NumberK202885
Device Name:GlucoSure HT Plus Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant Apex BioTechnology Corp. No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu,  CN 30078
ContactLisa Liu
CorrespondentLisa Liu
Apex BioTechnology 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 Received2020-09-28
Decision Date2021-09-15

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.