FDA 510(k) Application Details - K250117

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K250117
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	Assure Tech LLC 1521 Concord Pike, Suite 201 Wilmington, DE 19803 US Other 510(k) Applications for this Company
Contact	Shisheng Ling 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	01/16/2025
Decision Date	02/13/2025
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