CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237

Glucose Oxidase, Glucose

TaiDoc Technology Corporation

The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Chek And Audiochek Blood Glucose Monitoring Systems, Model Td-4237.

Pre-market Notification Details

Device IDK081609
510k NumberK081609
Device Name:CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237
ClassificationGlucose Oxidase, Glucose
Applicant TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County,  TW 248
ContactYuhua Chen
CorrespondentYuhua Chen
TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County,  TW 248
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-09
Decision Date2008-07-02

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