FDA 510(k) Application Details - K193514

Device Classification Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)   More FDA Info for this Device
510(K) Number	K193514
Device Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Applicant	Arkray Inc. Yousuien-Nai, 59 Gansuin-Cho Kamigyo-ku 602-0008 JP Other 510(k) Applications for this Company
Contact	Hideko Kosaka Other 510(k) Applications for this Contact
Regulation Number	862.1340   More FDA Info for this Regulation Number
Classification Product Code	JIL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2019
Decision Date	04/13/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review