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

FDA 510(k) Number Applicant Device Name Decision Date
K940595 ABBOTT LABORATORIES AXSYM VANCOMYCIN 06/21/1994
K955851 ABBOTT LABORATORIES AXSYM VANCOMYCIN II 05/09/1996
K821136 ABBOTT LABORATORIES TDX TM STREPTOMYCIN 05/13/1982
K813218 ABBOTT LABORATORIES TDX VANCOMYCIN 12/08/1981
K822308 AMERICAN DIAGNOSTIC CORP. VANCOMYCIN FLUORESCENT IMMUNOASSAY 08/16/1982
K874438 BAXTER HEALTHCARE CORP. STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY 01/21/1988
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
K951059 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY 06/19/1995
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
K892900 E.I. DUPONT DE NEMOURS & CO., INC. ACA VANCOMYCIN (VANC) METHOD 05/22/1989
K872579 INNOTRON OF OREGON, INC. INNOFLUOR VANCOMYCIN REAGENT SET 08/17/1987
K900708 INNOTRON OF OREGON, INC. MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR 04/19/1990
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
K924957 PB DIAGNOSTIC SYSTEMS, INC. OPUS(R) VANCOMYCIN 12/11/1992
K901759 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS-FP REAGENTS FOR VANCOMYCIN 05/02/1990
K953528 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN 09/12/1995
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
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
K881040 SYVA CO. EMIT VANCOMYCIN ASSAY 04/19/1988
K945125 THE DU PONT CO. DUPONT ACA VANCOMYCIN (VANC) METHOD 03/10/1995


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