FDA 510(k)

Assure Titanium Blood Glucose Monitoring System

K-Number: K200788 · 2022-05-23

Decision Date2022-05-23

Product CodePZI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Assure Titanium Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Arkray, Inc.. It received FDA 510(k) clearance on 2022-05-23 under 510(k) 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. The listed applicant is Arkray, Inc.. The 510(k) number is K200788.

When did Assure Titanium Blood Glucose Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for Assure Titanium Blood Glucose Monitoring System?

The FDA 510(k) record lists Arkray, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Arkray, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232416AUTION EYE AI-4510 Urine Particle Analysis System K193514AUTION MAX AX-4060 Urinalysis System K221175Multi-Lancet Device 2, ReliOn Premier Lancing Device K160062AUTION ELEVEN Semi-Automated Urinalysis System

Related Devices (Code: PZI)

K252323cobas pulse blood glucose monitoring systemRoche Diagnostics K221349XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemTaidoc Technology Corporation K220272cobas pulse blood glucose monitoring systemRoche Diagnostics K232075StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation K182552StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation K182549StatStrip Xpress 2 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.