FDA 510(k) Application Details - K242209

Device Classification Name	More FDA Info for this Device
510(K) Number	K242209
Device Name	UASure II Blood Uric Acid Monitoring System
Applicant	Apex Biotechnology Corp No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu 30078 TW Other 510(k) Applications for this Company
Contact	Lisa Liu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PTC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2024
Decision Date	04/04/2025
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