Cleared Special

EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

K111728 · Eps Bio Technology Corp. · Chemistry
Sep 2011
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K111728 is an FDA 510(k) clearance for the EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Eps Bio Technology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on September 16, 2011, 88 days after receiving the submission on June 20, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K111728 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2011
Decision Date September 16, 2011
Days to Decision 88 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

Similar Devices — CGA Glucose Oxidase, Glucose

All 399
YSI 2900C Biochemistry Analyzer
K210933 · Ysi, Inc. · Sep 2024
EasyStat 300
K220328 · Medica Corporation · Jul 2024
Cholestech LDX ? System
K223179 · Alere San Diego, Inc. · Sep 2023
i-STAT G cartridge with the i-STAT 1 System
K223755 · Abbott Point of Care, Inc. · Sep 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K223710 · Abbott Point of Care, Inc. · Jul 2023
GEM Premier ChemSTAT
K223090 · Instrumentation Laboratory CO · Jan 2023