FDA 510(k) Application Details - K240643

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K240643
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	Guangzhou Decheng Biotechnology Co., Ltd. Room 107/218/212/405, Building 2, No. 68, 1st Nanxiang Road Science City, Huangpu District Guangzhou 510000 CN Other 510(k) Applications for this Company
Contact	Weifang Liu 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	03/07/2024
Decision Date	06/21/2024
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