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 electrode, ion specific, urea nitrogen
510(k) Number K171247
Device Name epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
Applicant
Epocal Inc.
2060 Walkley Road
Ottawa,  CA K1G 3P5
Applicant Contact Jennifer Armstrong
Correspondent
Epocal Inc.
2060 Walkley Road
Ottawa,  CA K1G 3P5
Correspondent Contact Jennifer Armstrong
Regulation Number862.1770
Classification Product Code
CDS  
Subsequent Product Code
JFL  
Date Received04/28/2017
Decision Date 01/17/2018
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
-
-