FORA ADVANCED GD40 Glucose, ß-Ketone And Cholesterol Monitoring System

System, Test, Blood Glucose, Over The Counter

TaiDoc Technology Corporation

The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Advanced Gd40 Glucose, ß-ketone And Cholesterol Monitoring System.

Pre-market Notification Details

Device IDK201037
510k NumberK201037
Device Name:FORA ADVANCED GD40 Glucose, ß-Ketone And Cholesterol Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant TaiDoc Technology Corporation 6F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City,  TW 24888
ContactJacky Chou
CorrespondentJacky Chou
TaiDoc Technology Corporation B1-7F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City,  TW 24888
Product CodeNBW  
Subsequent Product CodeCHH
Subsequent Product CodeJIN
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-20
Decision Date2022-06-16

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