Cleared Special

EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

K112901 · Eps Bio Technology Corp. · Chemistry
Dec 2011
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K112901 is an FDA 510(k) clearance for the EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM, a Glucose Dehydrogenase, Glucose (Class II — Special Controls, product code LFR), submitted by Eps Bio Technology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on December 23, 2011, 81 days after receiving the submission on October 3, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K112901 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2011
Decision Date December 23, 2011
Days to Decision 81 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LFR — Glucose Dehydrogenase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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