FDA 510(k) Applications for Medical Device Product Code: LEH (Radioimmunoassay, Vancomycin)

FDA 510(k) Applications for Medical Device Product Code "LEH"
(Radioimmunoassay, Vancomycin)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K955851	ABBOTT LABORATORIES	AXSYM VANCOMYCIN II	05/09/1996
K964587	BAYER CORP.	VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM	01/13/1997
K013076	BECKMAN COULTER, INC.	SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR	12/12/2001
K123947	BIOKIT S.A.	ARCHITECT IVANCOMYCIN	08/29/2013
K072036	BIOKIT S.A.	ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01	03/19/2008
K020692	DADE BEHRING, INC.	EMIT 2000 VANCOMYCIN ASSAY	05/10/2002
K963267	DADE INTL., INC.	VANCOMYCIN FLEX REAGENT CARTRIDGE	09/13/1996
K063045	DIAGNOSTIC PRODUCTS CORP.	IMMULITE 2000, IMMULITE 2500 VANCOMYCIN	12/05/2006
K983280	DIAGNOSTIC REAGENTS, INC.	VANCOMYCIN EIA ASSAY	11/06/1998
K032811	MICROGENICS CORP.	CEDIA VANCOMYCIN ASSAY	11/24/2003
K043386	Ortho-Clinical Diagnostics, Inc.	VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III	02/07/2005
K060586	ROCHE DIAGNOSTICS CORP.	ENZYME IMMUNOASSAY, VANCOMYCIN	05/11/2006
K152245	ROCHE DIAGNOSTICS OPERATIONS (RDO)	ONLINE TDM Vancomycin Gen.3	01/08/2016
K050419	SERADYN INC.	QMS VANCOMYCIN	04/01/2005
K222439	Siemens Healthcare Diagnostics Inc.	Atellica« CH Phencyclidine (Pcp), Atellica« CH Vancomycin (Vanc)	08/08/2023
K160202	SIEMENS HEALTHCARE DIAGNOSTICS, INC.	Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)	04/27/2016
K955716	SIGMA DIAGNOSTICS, INC.	VANCOMYCIN FPIA REAGENT SET	02/16/1996