FDA 510(k) Application Details - K230741

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K230741
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. No.888, Zhujiang Road, Juegang Street, Rudong County (Life & Health of Rudong High-tech Zone) Nantong City, Jiangsu Nantong 226499 CN Other 510(k) Applications for this Company
Contact	Bella Xu 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	03/17/2023
Decision Date	10/13/2023
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