Cleared Special

MDT2 BLE Self-Monitoring Blood Glucose System

K190189 · Eps Bio Technology Corp. · Chemistry
Nov 2019
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K190189 is an FDA 510(k) clearance for the MDT2 BLE 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 November 1, 2019, 273 days after receiving the submission on February 1, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K190189 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2019
Decision Date November 01, 2019
Days to Decision 273 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

Similar Devices — NBW System, Test, Blood Glucose, Over The Counter

All 507
On Call? Sure GK Blood Glucose & Ketone Monitoring System; On Call? Sure Sync GK Blood Glucose & Ketone Monitoring System
K250085 · ACON Laboratories, Inc. · Oct 2025
TeleRPM Gen2 Blood Glucose Monitoring System
K243060 · Guangdong Transtek Medical Electronics Co., Ltd. · Jan 2025
RIGHTEST Blood Glucose Monitoring System Max Tel
K240637 · Bionime Corporation · Nov 2024
Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System
K240640 · Sejoy Biomedical Co., Ltd. · Oct 2024
CONTOUR? PLUS BLUE Blood Glucose Monitoring System; CONTOUR? NEXT GEN Blood Glucose Monitoring System
K241787 · Ascensia Diabetes Care U.S., Inc. · Aug 2024
VivaChek? Fad Blood Glucose Monitoring System, VivaChek? Fad Smart Blood Glucose Monitoring System, VivaChek? Fad Sync Blood Glucose Monitoring System
K222126 · Vivachek Biotech (Hangzhou) Co., Ltd. · Aug 2024