FDA 510(k) Application Details - K251053

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K251053
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	Hangzhou AllTest Biotech Co., Ltd. No. 550 Yinhai Street Hangzhou Economic & Technological Development Area Hangzhou 310018 CN Other 510(k) Applications for this Company
Contact	Rosa Wu 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	04/04/2025
Decision Date	07/15/2025
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