GLUCOCARD® W Onyx Blood Glucose Monitoring System

System, Test, Blood Glucose, Over The Counter

ARKRAY Factory, Inc.

The following data is part of a premarket notification filed by Arkray Factory, Inc. with the FDA for Glucocard® W Onyx Blood Glucose Monitoring System.

Pre-market Notification Details

• Device ID: K183306
• 510k Number: K183306
• Device Name: GLUCOCARD® W Onyx Blood Glucose Monitoring System
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: ARKRAY Factory, Inc. Yousuien-Nai, 59 Gansuin-Cho Kamigyo-ku, JP 602-0008
• Contact: Yoshiharu Uehata
• Correspondent: Dhwani Thakkar; Arkray America Inc. 5182 West 76th Street Edina, MN 55439
• Product Code: NBW
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-11-28
• Decision Date: 2019-04-10