Cleared Traditional

GlucoSure Link Blood Glucose Monitoring System

K212140 · Apex BioTechnology Corp. · Chemistry
Aug 2022
Decision
413d
Days
Class 2
Risk

About This 510(k) Submission

K212140 is an FDA 510(k) clearance for the GlucoSure Link Blood Glucose Monitoring System, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Apex BioTechnology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on August 25, 2022, 413 days after receiving the submission on July 8, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K212140 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2021
Decision Date August 25, 2022
Days to Decision 413 days
Submission Type Traditional
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