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FDA 510(k)

VivaChek Blood Glucose and B-Ketone Monitoring System

K-Number: K192957 · 2020-06-05

ApplicantVivachek Biotech (Hangzhou) Co., Ltd.
Decision Date2020-06-05
Product CodeJIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VivaChek Blood Glucose and B-Ketone Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2020-06-05 under 510(k) number K192957. 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 VivaChek Blood Glucose and B-Ketone Monitoring System?

VivaChek Blood Glucose and B-Ketone Monitoring System is a medical device that received FDA 510(k) clearance on 2020-06-05. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K192957.

When did VivaChek Blood Glucose and B-Ketone Monitoring System receive FDA 510(k) clearance?

VivaChek Blood Glucose and B-Ketone Monitoring System received FDA 510(k) clearance on 2020-06-05, under 510(k) number K192957.

Who is the listed applicant for VivaChek Blood Glucose and B-Ketone Monitoring System?

The FDA 510(k) record lists Vivachek Biotech (Hangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VivaChek Blood Glucose and B-Ketone Monitoring System?

The FDA product code for VivaChek Blood Glucose and B-Ketone Monitoring System is JIN.

Related Clinical Trials

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.

NCT06977633Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 DiabetesNOT_YET_RECRUITING

Other records listing Vivachek Biotech (Hangzhou) Co., Ltd. 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.K182593KET-1 Blood Ketone Monitoring SystemApex BioTechnology Corp.K173345TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology CorporationK170463KetoSens 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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