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FDA 510(k)

Assure Titanium Blood Glucose Monitoring System

K-Number: K200788 · 2022-05-23

ApplicantArkray, Inc.
Decision Date2022-05-23
Product CodePZI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Assure Titanium Blood Glucose Monitoring System is a medical device manufactured by Arkray, Inc.. It received FDA 510(k) clearance on 2022-05-23 under approval number K200788. The device is classified under product code PZI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Assure Titanium Blood Glucose Monitoring System?

Assure Titanium Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-05-23. It is manufactured by Arkray, Inc.. The 510(k) number is K200788.

When was Assure Titanium Blood Glucose Monitoring System approved by the FDA?

Assure Titanium Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-05-23, under approval number K200788.

What company makes Assure Titanium Blood Glucose Monitoring System?

Assure Titanium Blood Glucose Monitoring System is manufactured by Arkray, Inc..

What is the FDA product code for Assure Titanium Blood Glucose Monitoring System?

The FDA product code for Assure Titanium Blood Glucose Monitoring System is PZI.

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, Inc.

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Related Devices (Code: PZI)

K161856StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation K152986StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation K163490StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation K182552StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation K182549StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation K181043StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation

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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