TAIDOC CHECK

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 Taidoc Check.

Pre-market Notification Details

Device IDK041107
510k NumberK041107
Device Name:TAIDOC CHECK
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant TaiDoc Technology Corporation 4F, NO. 88, SEC.1, KWANG-FU RD SAN-CHUNG Taipei County,  TW 241
ContactShu-mei Wu
CorrespondentShu-mei Wu
TaiDoc Technology Corporation 4F, NO. 88, SEC.1, KWANG-FU RD SAN-CHUNG Taipei County,  TW 241
Product CodeNBW  
Subsequent Product CodeCGA
Subsequent Product CodeJJX
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-28
Decision Date2004-06-18
Summary:summary

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