Cleared Traditional

EPOC CHLORIDE TEST AND EPOC CREATININE TEST

K113726 · Epocal, Inc. · Chemistry
Oct 2012
Decision
291d
Days
Class 2
Risk

About This 510(k) Submission

K113726 is an FDA 510(k) clearance for the EPOC CHLORIDE TEST AND EPOC CREATININE TEST, a Electrode, Ion Based, Enzymatic, Creatinine (Class II — Special Controls, product code CGL), submitted by Epocal, Inc. (Ottawa, CA). The FDA issued a Cleared decision on October 5, 2012, 291 days after receiving the submission on December 19, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K113726 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2011
Decision Date October 05, 2012
Days to Decision 291 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGL — Electrode, Ion Based, Enzymatic, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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