Cleared Special

EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM

K133537 · Eps Bio Technology Corp. · Chemistry
Apr 2014
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K133537 is an FDA 510(k) clearance for the EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO 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 April 28, 2014, 161 days after receiving the submission on November 18, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K133537 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2013
Decision Date April 28, 2014
Days to Decision 161 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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