Cleared Traditional

EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM

K043245 · Eps Bio Technology Corp. · Chemistry
Apr 2005
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K043245 is an FDA 510(k) clearance for the EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Eps Bio Technology Corp. (Flagstaff, US). The FDA issued a Cleared decision on April 29, 2005, 157 days after receiving the submission on November 23, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K043245 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2004
Decision Date April 29, 2005
Days to Decision 157 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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