FDA 510(k) Application Details - K182593

Device Classification Name	Nitroprusside, Ketones (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K182593
Device Name	Nitroprusside, Ketones (Urinary, Non-Quant.)
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	862.1435   More FDA Info for this Regulation Number
Classification Product Code	JIN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2018
Decision Date	12/18/2018
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