FORA GD43 Blood Glucose 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 Gd43 Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK143467
510k NumberK143467
Device Name:FORA GD43 Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant TaiDoc Technology Corporation B1-7F, No.127, Wugong 2nd Rd., Wugu District New Taipei City,  TW 24888
ContactC. W. Chen
CorrespondentPaul Liu
TaiDoc Technology Corporation B1-7F, No.127, Wugong 2nd Rd., Wugu District New Taipei City,  TW 24888
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-04
Decision Date2015-05-07
Summary:summary

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