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 K112963
Device Name TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
Applicant
TaiDoc Technology Corporation
3F,5F, No.127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Applicant Contact TELING HSU
Correspondent
TaiDoc Technology Corporation
3F,5F, No.127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Correspondent Contact TELING HSU
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received10/05/2011
Decision Date 11/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-