FDA 510(k) Application Details - K242498

Device Classification Name	Test, Amphetamine, Over The Counter   More FDA Info for this Device
510(K) Number	K242498
Device Name	Test, Amphetamine, Over The Counter
Applicant	Aicheck Biotech, Inc. 17701 Cowan Ste 230 Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Lisa Liu 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	08/22/2024
Decision Date	10/01/2024
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