Cleared Traditional

EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017

K101037 · Eps Bio Technology Corp. · Chemistry
May 2011
Decision
404d
Days
Class 2
Risk

About This 510(k) Submission

K101037 is an FDA 510(k) clearance for the EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017, 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 23, 2011, 404 days after receiving the submission on April 14, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K101037 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2010
Decision Date May 23, 2011
Days to Decision 404 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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