FDA 510(k)

GLUCOCARD W Blood Glucose Monitoring System

K-Number: K170064 · 2017-08-16

Decision Date2017-08-16

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GLUCOCARD W Blood Glucose Monitoring System is a medical device manufactured by Arkray Factory, Inc.. It received FDA 510(k) clearance on 2017-08-16 under approval number K170064. 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 Blood Glucose Monitoring System?

GLUCOCARD W Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-08-16. It is manufactured by Arkray Factory, Inc.. The 510(k) number is K170064.

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

GLUCOCARD W Blood Glucose Monitoring System received FDA 510(k) clearance on 2017-08-16, under approval number K170064.

What company makes GLUCOCARD W Blood Glucose Monitoring System?

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

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

The FDA product code for GLUCOCARD W Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Related PubMed Literature

PMID: 41693672 Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report. Journal of diabetes science and technology (2026) PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 37272495 An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection. Journal of diabetes science and technology (2025)

Other Devices by Arkray Factory, Inc.

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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.