FDA 510(k) Application Details - K243996

Device Classification Name	Test, Amphetamine, Over The Counter   More FDA Info for this Device
510(K) Number	K243996
Device Name	Test, Amphetamine, Over The Counter
Applicant	Assure Tech LLC 1521 Concord Pike, Suite 201 Wilmington, DE 19803 US Other 510(k) Applications for this Company
Contact	Allen Chen 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	12/26/2024
Decision Date	02/07/2025
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