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FDA 510(k)

GLUCOCARD® W onyx Blood Glucose Monitoring System

K-Number: K183306 · 2019-04-10

ApplicantArkray Factory, Inc.
Decision Date2019-04-10
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOCARD® W onyx Blood Glucose Monitoring System is a medical device manufactured by Arkray Factory, Inc.. It received FDA 510(k) clearance on 2019-04-10 under approval number K183306. 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 GLUCOCARD® W onyx Blood Glucose Monitoring System?

GLUCOCARD® W onyx Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2019-04-10. It is manufactured by Arkray Factory, Inc.. The 510(k) number is K183306.

When was GLUCOCARD® W onyx Blood Glucose Monitoring System approved by the FDA?

GLUCOCARD® W onyx Blood Glucose Monitoring System received FDA 510(k) clearance on 2019-04-10, under approval number K183306.

What company makes GLUCOCARD® W onyx Blood Glucose Monitoring System?

GLUCOCARD® W onyx Blood Glucose Monitoring System is manufactured by Arkray Factory, Inc..

What is the FDA product code for GLUCOCARD® W onyx Blood Glucose Monitoring System?

The FDA product code for GLUCOCARD® W onyx Blood Glucose 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 Arkray Factory, Inc.

K170064GLUCOCARD W Blood Glucose Monitoring System K162822ADAMS A1c HA-8180V, CALIBRATOR 80

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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