FDA 510(k) Applications for Medical Device Product Code: MKU (Enzyme Immunoassasy, Nocotine And Nicotine Metabolites)

FDA 510(k) Applications for Medical Device Product Code "MKU"
(Enzyme Immunoassasy, Nocotine And Nicotine Metabolites)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K021944	COZART BIOSCIENCE LTD.	COZART EIA COTININE URINE KIT	05/14/2003
K192299	Lin-Zhi International, Inc.	LZI Cotinine II Enzyme Immunoassay	11/21/2019
K972481	ORASURE TECHNOLOGIES, INC.	AUTO-LYTE COTININE EIA	10/21/1997
K974234	ORASURE TECHNOLOGIES, INC.	MICRO-PLATE COTININE EIA	05/14/1998
K974534	ORASURE TECHNOLOGIES, INC.	MICRO-PLATE COTININE EIA	05/18/1998
K062565	PRINCETON BIOMEDITECH CORP.	STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE	02/20/2007
K192517	Psychemedics Corporation	Psychemedics Microplate EIA for Cotinine in Hair	04/22/2020