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FDA 510(k)

GAL-1A Plus Blood Glucose Monitoring System

K-Number: K213887 · 2022-03-29

ApplicantApex BioTechnology Corp.
Decision Date2022-03-29
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAL-1A Plus Blood Glucose Monitoring System is a medical device manufactured by Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2022-03-29 under approval number K213887. 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 GAL-1A Plus Blood Glucose Monitoring System?

GAL-1A Plus Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-03-29. It is manufactured by Apex BioTechnology Corp.. The 510(k) number is K213887.

When was GAL-1A Plus Blood Glucose Monitoring System approved by the FDA?

GAL-1A Plus Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-03-29, under approval number K213887.

What company makes GAL-1A Plus Blood Glucose Monitoring System?

GAL-1A Plus Blood Glucose Monitoring System is manufactured by Apex BioTechnology Corp..

What is the FDA product code for GAL-1A Plus Blood Glucose Monitoring System?

The FDA product code for GAL-1A Plus Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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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 K201880MultiSure GK Link Blood Glucose and Ketone Monitoring System K202885GlucoSure HT Plus Blood Glucose Monitoring System

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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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