Cleared Special

EasyMax BT Self-Monitoring Blood Glucose System

K182057 · Eps Bio Technology Corp. · Chemistry
Aug 2018
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K182057 is an FDA 510(k) clearance for the EasyMax BT 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 August 24, 2018, 24 days after receiving the submission on July 31, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K182057 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2018
Decision Date August 24, 2018
Days to Decision 24 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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