FDA 510(k) Application Details - K221550

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K221550
Device Name	Enzyme Immunoassay, Opiates
Applicant	Randox Laboratories Limited 55 Diamond Road Crumlin BT29 4QY GB Other 510(k) Applications for this Company
Contact	Karena Shaw 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	05/31/2022
Decision Date	10/05/2023
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