FDA 510(k) Application Details - K240295

Device Classification Name	Test, Opiates, Over The Counter   More FDA Info for this Device
510(K) Number	K240295
Device Name	Test, Opiates, Over The Counter
Applicant	Instanosis Inc 1004 w 9th Avenue Suite 10 King of Prussia, PA 19406 US Other 510(k) Applications for this Company
Contact	Xiaofeng Xia Other 510(k) Applications for this Contact
Regulation Number	862.3650   More FDA Info for this Regulation Number
Classification Product Code	NGL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2024
Decision Date	03/28/2024
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