TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM

Glucose Dehydrogenase, Glucose

TaiDoc Technology Corporation

The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Td-4268 Blood Glucose Monitoring System Td-4268 Multi Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK120042
510k NumberK120042
Device Name:TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM
ClassificationGlucose Dehydrogenase, Glucose
Applicant TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd. Wugu District New Taipei City,  TW 24888
ContactMeiru Li
CorrespondentMeiru Li
TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd. Wugu District New Taipei City,  TW 24888
Product CodeLFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-05
Decision Date2012-05-22
Summary:summary

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