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FDA 510(k)

OneTouch Verio Reflect Blood Glucose Monitoring System

K-Number: K193475 · 2020-02-14

ApplicantLifescan Europe GmbH
Decision Date2020-02-14
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OneTouch Verio Reflect Blood Glucose Monitoring System is a medical device manufactured by Lifescan Europe GmbH. It received FDA 510(k) clearance on 2020-02-14 under approval number K193475. 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 OneTouch Verio Reflect Blood Glucose Monitoring System?

OneTouch Verio Reflect Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2020-02-14. It is manufactured by Lifescan Europe GmbH. The 510(k) number is K193475.

When was OneTouch Verio Reflect Blood Glucose Monitoring System approved by the FDA?

OneTouch Verio Reflect Blood Glucose Monitoring System received FDA 510(k) clearance on 2020-02-14, under approval number K193475.

What company makes OneTouch Verio Reflect Blood Glucose Monitoring System?

OneTouch Verio Reflect Blood Glucose Monitoring System is manufactured by Lifescan Europe GmbH.

What is the FDA product code for OneTouch Verio Reflect Blood Glucose Monitoring System?

The FDA product code for OneTouch Verio Reflect 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)

Related Devices (Code: NBW)

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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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