• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

OTC - Over The Counter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back to Search Results
Document NumberK042005/A002
Test Name Taidoc Technology easy check TD-4209 Blood Glucose Monitoring System   
Manufacturer NameTaiDoc Technology Corporation
Consumer Information Phone Number(800)915-0116
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date06/30/2006
Device Classification Name system, test, blood glucose, over the counter
510(k) Number K042005
Device Name ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222
Applicant
TaiDoc Technology Corporation
4F, 88, SEC.1, KWANG FU ROAD
SAN CHUNG, TAIPEI,  TW 241
Applicant Contact SHU-MEI WU
Correspondent
TaiDoc Technology Corporation
4F, 88, SEC.1, KWANG FU ROAD
SAN CHUNG, TAIPEI,  TW 241
Correspondent Contact SHU-MEI WU
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received07/26/2004
Decision Date 08/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-