FDA 510(k) Application Details - K192515

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K192515
Device Name	Enzyme Immunoassay, Cannabinoids
Applicant	Shenzhen Bioeasy Biotechnology Co.,Ltd. No.2-1, Liuxian 1st Road, Xin'an Sub-District Shenzhen 518101 CN Other 510(k) Applications for this Company
Contact	Wenhau Yan 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	09/13/2019
Decision Date	10/11/2019
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