Assure Titanium Blood Glucose Monitoring System— 510(k) K200788

Substantially Equivalent

Arkray, Inc.

FDA 510(k) clearance K200788 for Assure Titanium Blood Glucose Monitoring System, Substantially Equivalent on 2022-05-23. Applicant: Arkray, Inc..

Clearance details

Applicant: Arkray, Inc.
Product code: Code PZI
Advisory panel: Clinical Chemistry
Date received: 2020-03-26
Decision date: 2022-05-23
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Kamigyo-Ku, JP

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