FDA 510(k) Application Details - K220685

Device Classification Name	Test, Amphetamine, Over The Counter   More FDA Info for this Device
510(K) Number	K220685
Device Name	Test, Amphetamine, Over The Counter
Applicant	Qingdao HIGHTOP Biotech Co., Ltd. No.369 Hedong Road, Hi-tech Industrial Development Zone Qingdao 266112 CN Other 510(k) Applications for this Company
Contact	Ray Li 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	03/08/2022
Decision Date	05/05/2022
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