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 Glucose Oxidase, Glucose
510(k) Number K111728
Device Name EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
Applicant
Eps Bio Technology Corp.
# 8 R&D Rd.Iii, Hsinchu Science Park
Hsinchu,  TW 30077
Applicant Contact YC LEI
Correspondent
Eps Bio Technology Corp.
# 8 R&D Rd.Iii, Hsinchu Science Park
Hsinchu,  TW 30077
Correspondent Contact YC LEI
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received06/20/2011
Decision Date 09/16/2011
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
Predetermined Change
Control Plan Authorized		 No
-
-