FDA 510(k) Application Details - K200788

Device Classification Name	More FDA Info for this Device
510(K) Number	K200788
Device Name	Assure Titanium Blood Glucose Monitoring System
Applicant	Arkray, Inc. Yousuien-nai, Gansuin-cho Kamigyo-ku 602-0008 JP Other 510(k) Applications for this Company
Contact	Yosiharu Uehata Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2020
Decision Date	05/23/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review