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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, ion specific, urea nitrogen
510(k) Number K171247
Device Name epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
Epocal Inc.
2060 Walkley Road
Ottawa,  CA K1G 3P5
Applicant Contact Jennifer Armstrong
Epocal Inc.
2060 Walkley Road
Ottawa,  CA K1G 3P5
Correspondent Contact Jennifer Armstrong
Regulation Number862.1770
Classification Product Code
Subsequent Product Code
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