FDA 510(k) Applications for Medical Device Product Code: LCD (Enzyme Immunoassay, Gentamicin)

FDA 510(k) Applications for Medical Device Product Code "LCD"
(Enzyme Immunoassay, Gentamicin)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K102699	ABBOTT LABORATORIES	ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS	04/01/2011
K962519	BEHRING DIAGNOSTICS, INC.	EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS	09/04/1996
K962819	DADE INTL., INC.	GENTAMICIN FLEX REAGENT CARTRIDGE	09/13/1996
K012311	DIAGNOSTIC PRODUCTS CORP.	IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)	08/20/2001
K042479	Ortho-Clinical Diagnostics, Inc.	VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE	01/06/2005
K012978	RANDOX LABORATORIES, LTD.	RANDOX GENTAMICIN	09/18/2001
K020704	ROCHE DIAGNOSTICS CORP.	ROCHE ONLINE GENTAMICIN	07/12/2002
K060709	SERADYN INC.	MULTIGENT GENTAMICIN	06/15/2006
K010984	SYVA CO., DADE BEHRING, INC.	EMIT 2000 GENTAMICIN PLUS ASSAY	04/20/2001