FDA 510(k) Applications for Medical Device Product Code "LFM"
(Enzyme Immunoassay, Digitoxin)

FDA 510(k) Number Applicant Device Name Decision Date
K963158 ABBOTT LABORATORIES ABBOTT AXSYM DIGITOXIN (MODIFY) 09/10/1996
K954420 ABBOTT LABORATORIES AXSYM DIGITOXIN 12/29/1995
K842280 ABBOTT LABORATORIES TDX DIGITOXIN 08/16/1984
K862067 AMERICAN DADE STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY 06/16/1986
K951631 BAYER CORP. DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS 06/09/1995
K970546 CHIRON DIAGNOSTICS CORP. ACS DIGITOXIN 07/14/1997
K990251 DADE BEHRING, INC. DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 03/31/1999
K062024 DADE BEHRING, INC. DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE 07/28/2006
K943235 DIAGNOSTIC PRODUCTS CORP. IMMULITE DIGITOXIN 10/27/1994
K900013 DIAGNOSTIC PRODUCTS CORP. MILENIA (TM) DIGITOXIN 03/09/1990
K830035 DIAGNOSTIC PRODUCTS CORP. SOPHEIA DIGITOXIN EIA KIT & COMPONENTS 01/28/1983
K842578 DIAGNOSTIC PRODUCTS CORP. SOPHEIA/MP DIGITOXIN EIA KIT 08/12/1984
K891094 E.I. DUPONT DE NEMOURS & CO., INC. ACA(R) DIGITOXIN (DGTX) METHOD 04/26/1989
K942610 EASTMAN KODAK COMPANY KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) 10/20/1994
K913187 INTL. BIOCLINICAL, INC. INNOFLUOR(TM) DIGITOXIN REAGENT SET 09/23/1991
K896021 MICROGENICS CORP. CEDIA DIGITOXIN ASSAY 11/08/1989
K012112 RANDOX LABORATORIES, LTD. RANDOX DIGITOXIN 01/11/2002
K915465 SIGMA DIAGNOSTICS, INC. DIGITOXIN FPIA REAGENT SET 01/27/1992
K942619 SYVA CO. EMIT 2000 DIGOXIN ASSAY/CALIBRATORS 09/20/1994
K913240 TUDOR LABORATORIES, INC. DIGITOXIN (FPIA) KIT 09/06/1991


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