MultiSure GK Link Blood Glucose And Ketone 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 Multisure Gk Link Blood Glucose And Ketone Monitoring System.

Pre-market Notification Details

Device IDK201880
510k NumberK201880
Device Name:MultiSure GK Link Blood Glucose And Ketone Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant Apex Biotechnology Corp. No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu,  TW 30078
ContactLisu 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-07
Decision Date2021-10-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850017460065 K201880 000
00850017460034 K201880 000
00850017460027 K201880 000
00850017460287 K201880 000
00850017460089 K201880 000

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