Cleared Special

EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM

K133647 · Eps Bio Technology Corp. · Chemistry
Feb 2014
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K133647 is an FDA 510(k) clearance for the EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 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, TW). The FDA issued a Cleared decision on February 27, 2014, 92 days after receiving the submission on November 27, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K133647 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 2013
Decision Date February 27, 2014
Days to Decision 92 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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