CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225

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 Clever Chek Td-4209 Blood Glucose Monitoring System, Model Td-4209, Td-4222, Td-4225.

Pre-market Notification Details

Device IDK071493
510k NumberK071493
Device Name:CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD SAN CHUNG,TAIPEI COUNTY R.O.C. San Chung, Taipei,  TW 241
ContactErica Li
CorrespondentErica Li
TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD SAN CHUNG,TAIPEI COUNTY R.O.C. San Chung, Taipei,  TW 241
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-30
Decision Date2007-10-26
Summary:summary

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