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FDA 510(k)

Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System

K-Number: K240640 · 2024-10-08

ApplicantSejoy Biomedical Co., Ltd.
Decision Date2024-10-08
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System is a medical device manufactured by Sejoy Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2024-10-08 under approval number K240640. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System?

Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2024-10-08. It is manufactured by Sejoy Biomedical Co., Ltd.. The 510(k) number is K240640.

When was Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System approved by the FDA?

Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System received FDA 510(k) clearance on 2024-10-08, under approval number K240640.

What company makes Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System?

Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System is manufactured by Sejoy Biomedical Co., Ltd..

What is the FDA product code for Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System?

The FDA product code for Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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)

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Official Source

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