Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • 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
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K051854
Device Name CLEVER CHEK TD-4225, MODEL TD-4225
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 Received07/08/2005
Decision Date 08/05/2005
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
-
-