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 K182428
Device Name GlucoLeader Enhance Blood Glucose Monitoring System
Applicant
Hmd Biomedical, Inc.
# 181 Minsheng St., Xinpu Township
Hsin Chu County,  TW 30542
Applicant Contact Jen Ke-Min
Correspondent
Chinese-European Industrial Research Society
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Correspondent Contact Ke-Min Jen
Regulation Number862.1345
Classification Product Code
NBW  
Date Received09/06/2018
Decision Date 05/08/2019
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
-
-