Cleared Traditional

EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2

K070053 · Eps Bio Technology Corp. · Chemistry
Dec 2007
Decision
333d
Days
Class 2
Risk

About This 510(k) Submission

K070053 is an FDA 510(k) clearance for the EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Eps Bio Technology Corp. (Hsinchu City, TW). The FDA issued a Cleared decision on December 3, 2007, 333 days after receiving the submission on January 4, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K070053 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 2007
Decision Date December 03, 2007
Days to Decision 333 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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