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FDA 510(k)

MultiSure GK Link Blood Glucose and Ketone Monitoring System

K-Number: K201880 · 2021-10-15

ApplicantApex BioTechnology Corp.
Decision Date2021-10-15
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MultiSure GK Link Blood Glucose and Ketone Monitoring System is a medical device manufactured by Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2021-10-15 under approval number K201880. 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 MultiSure GK Link Blood Glucose and Ketone Monitoring System?

MultiSure GK Link Blood Glucose and Ketone Monitoring System is a medical device that received FDA 510(k) clearance on 2021-10-15. It is manufactured by Apex BioTechnology Corp.. The 510(k) number is K201880.

When was MultiSure GK Link Blood Glucose and Ketone Monitoring System approved by the FDA?

MultiSure GK Link Blood Glucose and Ketone Monitoring System received FDA 510(k) clearance on 2021-10-15, under approval number K201880.

What company makes MultiSure GK Link Blood Glucose and Ketone Monitoring System?

MultiSure GK Link Blood Glucose and Ketone Monitoring System is manufactured by Apex BioTechnology Corp..

What is the FDA product code for MultiSure GK Link Blood Glucose and Ketone Monitoring System?

The FDA product code for MultiSure GK Link Blood Glucose and Ketone Monitoring System is NBW. This falls under the OB/GYN category.

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 Apex BioTechnology Corp.

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System K170267BGM009 Plus Blood Glucose Monitoring System K182593KET-1 Blood Ketone Monitoring System K182992BGM014 Blood Glucose Monitoring System K202885GlucoSure HT Plus Blood Glucose Monitoring System K222234GlucoSure ADVANCE Link Blood Glucose Monitoring System

View all 12 devices →

Related Devices (Code: NBW)

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring SystemsTaidoc Technology Corporation K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemInfopia 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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