Cleared Special

EASYMAX Tag Self-Monitoring Blood Glucose System

K201258 · Eps Bio Technology Corp. · Chemistry
Sep 2021
Decision
478d
Days
Class 2
Risk

About This 510(k) Submission

K201258 is an FDA 510(k) clearance for the EASYMAX Tag Self-Monitoring Blood Glucose System, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Eps Bio Technology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on September 1, 2021, 478 days after receiving the submission on May 11, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K201258 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2020
Decision Date September 01, 2021
Days to Decision 478 days
Submission Type Special
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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