FDA 510(k) Application Details - K240124

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K240124
Device Name	Enzyme Immunoassay, Opiates
Applicant	VivaChek Biotech (Hangzhou) Co., Ltd Level 2, Block 2, 146 East Chaofeng Rd. Yuhang Economy Development Zone Hangzhou 311100 CN Other 510(k) Applications for this Company
Contact	Max Zhang Other 510(k) Applications for this Contact
Regulation Number	862.3650   More FDA Info for this Regulation Number
Classification Product Code	DJG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2024
Decision Date	06/14/2024
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