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 K193475
Device Name OneTouch Verio Reflect Blood Glucose Monitoring System
Applicant
Lifescan Europe GmbH
Gubelstrasse 34
Zug,  CH Ch-6300
Applicant Contact Niki Skelly
Correspondent
Lifescan Scotland, Ltd.
Beechwood Park N.
Inverness,  GB iv1 3ed
Correspondent Contact Niki Skelly
Regulation Number862.1345
Classification Product Code
NBW  
Date Received12/16/2019
Decision Date 02/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT03851549
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-