Cleared Traditional

K113243 - EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
(FDA 510(k) Clearance)

K113243 · Eps Bio Technology Corp. · Chemistry

Mar 2012

Decision

147d

Days

Class 2

Risk

K113243 is an FDA 510(k) clearance for the EM50 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 March 28, 2012, 147 days after receiving the submission on November 2, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K113243 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2011
Decision Date	March 28, 2012
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement