FDA 510(k) Application Details - K242135

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K242135
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	Nanjing Synthgene Medical Technology Co., Ltd. Building B6-2, No. 9, Weidi Road, Xianlin University Town Xianlin Subdistrict, Qixia District Nanjing 210000 CN Other 510(k) Applications for this Company
Contact	Alvin Qian 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	07/22/2024
Decision Date	01/31/2025
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