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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 the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2018-05-04 under 510(k) 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. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K173345.

When did TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System?

The FDA 510(k) record lists Taidoc Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

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Other records listing Taidoc Technology Corporation as applicant

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Related Devices (Code: JIN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

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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