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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prescription use blood glucose meter for near-patient testing
510(k) Number K200788
Device Name Assure Titanium Blood Glucose Monitoring System
Applicant
Arkray, Inc.
Yousuien-nai, Gansuin-cho
Kamigyo-ku,  JP 602-0008
Applicant Contact Yosiharu Uehata
Correspondent
Arkray Factory USA, Inc.
5182 West 76th Street
Minneapolis,  MN  55439
Correspondent Contact Dhwani Thakkar
Regulation Number862.1345
Classification Product Code
PZI  
Date Received03/26/2020
Decision Date 05/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
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