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510(k) K171247

epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test by Epocal, Inc. — Product Code CDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2018
Date Received
April 28, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

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  • K090109 — BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD (June 24, 2009)
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