FDA 510(k) Application Details - K183097

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K183097
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	Weihai Kangzhou Biotechnology Engineering Co., Ltd Room401, Building B, Innovation Entrepreneurship Base, High District Weihai City 264200 CN Other 510(k) Applications for this Company
Contact	Yong Qi 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	11/07/2018
Decision Date	01/10/2019
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