EPOC CHLORIDE TEST AND EPOC CREATININE TEST— 510(k) K113726

Name: FDA 510(k) clearance K113726
Creator: U.S. Food and Drug Administration
Published: 2012-10-05

Substantially Equivalent

Epocal, Inc.

FDA 510(k) clearance K113726 for EPOC CHLORIDE TEST AND EPOC CREATININE TEST, Substantially Equivalent on 2012-10-05. Applicant: Epocal, Inc.. Device class: 2.

Clearance details

Applicant: Epocal, Inc.
Product code: Code CGL
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2011-12-19
Decision date: 2012-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, CA

Download summary PDF View on FDA.gov ↗

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