VivaChek Blood Glucose and B-Ketone Monitoring System
K-Number: K192957 · 2020-06-05
Decision Date2020-06-05
Product CodeJIN
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
VivaChek Blood Glucose and B-Ketone Monitoring System is a medical device manufactured by Vivachek Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2020-06-05 under approval 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. It is manufactured by Vivachek Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K192957.
When was VivaChek Blood Glucose and B-Ketone Monitoring System approved by the FDA?
VivaChek Blood Glucose and B-Ketone Monitoring System received FDA 510(k) clearance on 2020-06-05, under approval number K192957.
What company makes VivaChek Blood Glucose and B-Ketone Monitoring System?
VivaChek Blood Glucose and B-Ketone Monitoring System is manufactured by Vivachek Biotech (Hangzhou) Co., Ltd..
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
NCT01143558
Searching for Persistence of Infection in Lyme Disease
COMPLETED
NCT07614139
Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders
COMPLETED
NCT06727942
Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes
RECRUITING
NCT01143454
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
RECRUITING
NCT01174108
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
RECRUITING
NCT07614100
Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves
NOT_YET_RECRUITING
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 Vivachek Biotech (Hangzhou) Co., Ltd.
K222667Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
K233058VivaChek Link Plus Blood Glucose Monitoring System
K233062BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
K231978BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50
K241869BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader
K222126VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System
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.
K173345TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology Corporation
K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc.
K201551KetoSens BT Blood B-Ketone Monitoring SystemI-Sens, 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.