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 K132633
Device Name OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Ok Biotech Co., Ltd.
# 91, Sec. 2
Gongdaowu Rd.
Hsinchu City,  TW 30070
Applicant Contact JEN KE-MIN
Correspondent
Ok Biotech Co., Ltd.
# 91, Sec. 2
Gongdaowu Rd.
Hsinchu City,  TW 30070
Correspondent Contact JEN KE-MIN
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received08/22/2013
Decision Date 08/14/2014
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
-
-