FDA 510(k) Application Details - K232416

Device Classification Name	Counter, Urine Particle   More FDA Info for this Device
510(K) Number	K232416
Device Name	Counter, Urine Particle
Applicant	Arkray Inc. Yousuien-Nai, 59 Gansuin-Cho Kamigyo-ku Kyoto 602-0008 JP Other 510(k) Applications for this Company
Contact	Shinya Nakajima Other 510(k) Applications for this Contact
Regulation Number	864.5200   More FDA Info for this Regulation Number
Classification Product Code	LKM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2023
Decision Date	05/03/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review