FDA 510(k) Application Details - K232864

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K232864
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	Nantong Egens Biotechnology Co.,Ltd. No 1692 Xinghu Avenue Nantong Economy&Technology Development Zone Nantong 226010 CN Other 510(k) Applications for this Company
Contact	Ouweijun . 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	09/15/2023
Decision Date	01/26/2024
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