FORACARE GD20 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 Foracare Gd20 Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK124040
510k NumberK124040
Device Name:FORACARE GD20 BLOOD GLUCOSE 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 241
ContactPinjung Chen
CorrespondentPinjung Chen
TaiDoc Technology Corporation 6F NO.127, WUGONG 2ND RD., WUGU DISTRICT New Taipei City,  TW 241
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-28
Decision Date2013-05-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04897137180011 K124040 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.