FDA 510(k) Application Details - K223162

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K223162
Device Name	Enzyme Immunoassay, Cannabinoids
Applicant	Healgen Scientific LLC 5213 Maple St Bellaire, TX 77401 US Other 510(k) Applications for this Company
Contact	Jianqiu Fang Other 510(k) Applications for this Contact
Regulation Number	862.3870   More FDA Info for this Regulation Number
Classification Product Code	LDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2022
Decision Date	03/17/2023
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