Cleared Special

EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM

K092894 · Eps Bio Technology Corp. · Chemistry
Feb 2010
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K092894 is an FDA 510(k) clearance for the EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Eps Bio Technology Corp. (Hsinchu City, TW). The FDA issued a Cleared decision on February 24, 2010, 156 days after receiving the submission on September 21, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K092894 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2009
Decision Date February 24, 2010
Days to Decision 156 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code NBW — System, Test, Blood Glucose, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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