FDA 510(k)

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system

K-Number: K213131 · 2023-08-10

Decision Date2023-08-10

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is a medical device manufactured by Roche Diabetes Care GmbH. It received FDA 510(k) clearance on 2023-08-10 under approval number K213131. 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 Accu-Chek Guide Solo diabetes manager blood glucose monitoring system?

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is a medical device that received FDA 510(k) clearance on 2023-08-10. It is manufactured by Roche Diabetes Care GmbH. The 510(k) number is K213131.

When was Accu-Chek Guide Solo diabetes manager blood glucose monitoring system approved by the FDA?

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system received FDA 510(k) clearance on 2023-08-10, under approval number K213131.

What company makes Accu-Chek Guide Solo diabetes manager blood glucose monitoring system?

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is manufactured by Roche Diabetes Care GmbH.

What is the FDA product code for Accu-Chek Guide Solo diabetes manager blood glucose monitoring system?

The FDA product code for Accu-Chek Guide Solo diabetes manager 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 Roche Diabetes Care GmbH

K213134Accu-Chek Solo micropump system with interoperable technology

Related Devices (Code: NBW)

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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.