Cleared Special

EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

K121207 · Eps Bio Technology Corp. · Chemistry
May 2012
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K121207 is an FDA 510(k) clearance for the EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU 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 May 18, 2012, 28 days after receiving the submission on April 20, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K121207 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2012
Decision Date May 18, 2012
Days to Decision 28 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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