Cleared Special

EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008

K083099 · Eps Bio Technology Corp. · Chemistry
Jan 2009
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K083099 is an FDA 510(k) clearance for the EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008, 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 January 16, 2009, 88 days after receiving the submission on October 20, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K083099 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 2008
Decision Date January 16, 2009
Days to Decision 88 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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