FDA 510(k) Application Details - K193132

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K193132
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
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	862.1155   More FDA Info for this Regulation Number
Classification Product Code	LCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2019
Decision Date	12/11/2019
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