FDA 510(k) Application Details - K221871

Device Classification Name	Test, Amphetamine, Over The Counter   More FDA Info for this Device
510(K) Number	K221871
Device Name	Test, Amphetamine, Over The Counter
Applicant	Healstone Biotech Inc Unit 650 - 655 West Kent Avenue North Vancouver V6P 6T7 CA Other 510(k) Applications for this Company
Contact	Bryan Fang 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	06/28/2022
Decision Date	08/30/2022
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