U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM

Glucose Oxidase, Glucose

TaiDoc Technology Corporation

The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for U-right Td-4249/u-right Td-4250 Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK083570
510k NumberK083570
Device Name:U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM
ClassificationGlucose Oxidase, Glucose
Applicant TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County,  TW 241
ContactSophie Lin
CorrespondentSophie Lin
TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County,  TW 241
Product CodeCGA  
Subsequent Product CodeJJX
Subsequent Product CodeNBW
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-03
Decision Date2009-03-11

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