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 Nitroprusside, Ketones (Urinary, Non-Quant.)
510(k) Number K173345
Device Name TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
Applicant
Taidoc Technology Corporation
B1-7f, #127, Wugong 2nd Rd.
New Taipei City,  TW 24888
Applicant Contact Sheena Song
Correspondent
Taidoc Technology Corporation
B1-7f, #127, Wugong 2nd Rd.
New Taipei City,  TW 24888
Correspondent Contact Anne Kuo
Regulation Number862.1435
Classification Product Code
JIN  
Date Received10/24/2017
Decision Date 05/04/2018
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
Predetermined Change
Control Plan Authorized		 No
-
-