FDA 510(k) Application Details - K243365

Device Classification Name	Test, Opiates, Over The Counter   More FDA Info for this Device
510(K) Number	K243365
Device Name	Test, Opiates, Over The Counter
Applicant	Healgen Scientific LLC 3818 Fuqua St Houston, TX 77047 US Other 510(k) Applications for this Company
Contact	Jianqiu Fang 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	10/29/2024
Decision Date	12/17/2024
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