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FDA 510(k)

TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System

K-Number: K173345 · 2018-05-04

ApplicantTaidoc Technology Corporation
Decision Date2018-05-04
Product CodeJIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System is a medical device manufactured by Taidoc Technology Corporation. It received FDA 510(k) clearance on 2018-05-04 under approval number K173345. The device is classified under product code JIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System?

TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System is a medical device that received FDA 510(k) clearance on 2018-05-04. It is manufactured by Taidoc Technology Corporation. The 510(k) number is K173345.

When was TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System approved by the FDA?

TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System received FDA 510(k) clearance on 2018-05-04, under approval number K173345.

What company makes TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System?

TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System is manufactured by Taidoc Technology Corporation.

What is the FDA product code for TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System?

The FDA product code for TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System is JIN.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41964171 Journal of diabetes science and technology (2026) PMID: 41760572 Trends in use of continuous glucose monitors among individuals with type 2 diabetes enrolled in Medicare Advantage (2021-2023). Journal of managed care & specialty pharmacy (2026)

Other Devices by Taidoc Technology Corporation

K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems K152680TD-1035 Thermometer K151024Finger Type Pulse Oximeter K142664URight Hemoglobin A1c system, FORA A1c System K162382Smart Dongle Blood Glucose Monitoring System K180863FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator

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Related Devices (Code: JIN)

K170587On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for UrinalysisACON Laboratories, Inc. K182593KET-1 Blood Ketone Monitoring SystemApex BioTechnology Corp. K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc. K201551KetoSens BT Blood B-Ketone Monitoring SystemI-Sens, Inc. K192957VivaChek Blood Glucose and B-Ketone Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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