FDA 510(k) Application Details - K180255

Device Classification Name	More FDA Info for this Device
510(K) Number	K180255
Device Name	CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Applicant	Hangzhou Clongene Biotech Co.,Ltd. Building 4, No.20 Longquan Road, Yuhang District Hangzhou 311121 CN Other 510(k) Applications for this Company
Contact	Zheng Shujian Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PTH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/30/2018
Decision Date	02/28/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review