Cleared Traditional

epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test

K171247 · Epocal, Inc. · Chemistry
Jan 2018
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K171247 is an FDA 510(k) clearance for the epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test, a Electrode, Ion Specific, Urea Nitrogen (Class II — Special Controls, product code CDS), submitted by Epocal, Inc. (Ottawa, CA). The FDA issued a Cleared decision on January 17, 2018, 264 days after receiving the submission on April 28, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K171247 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2017
Decision Date January 17, 2018
Days to Decision 264 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDS — Electrode, Ion Specific, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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