FDA 510(k) Application Details - K244043

Device Classification Name	Test, Amphetamine, Over The Counter   More FDA Info for this Device
510(K) Number	K244043
Device Name	Test, Amphetamine, Over The Counter
Applicant	Hangzhou Alltest Biotech Co.,Ltd #550, Yinhai Street Hangzhou 310018 CN Other 510(k) Applications for this Company
Contact	Rosa Wu Other 510(k) Applications for this Contact
Regulation Number	862.3100   More FDA Info for this Regulation Number
Classification Product Code	NFT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2024
Decision Date	02/27/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review