BGM039 Blood Glucose Monitoring System, BGM039 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 Bgm039 Blood Glucose Monitoring System, Bgm039 Link Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK220421
510k NumberK220421
Device Name:BGM039 Blood Glucose Monitoring System, BGM039 Link 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,  CN 30078
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-14
Decision Date2022-11-04

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