FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K061249 |
ABBOTT LABORATORIES |
AXSYM DIGOXIN III |
06/02/2006 |
K980521 |
BAYER CORP. |
DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS |
04/02/1998 |
K033007 |
BAYER DIAGNOSTICS CORP. |
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM |
11/14/2003 |
K983151 |
BECKMAN COULTER, INC. |
IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT |
11/05/1998 |
K982935 |
BECKMAN COULTER, INC. |
SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR |
10/14/1998 |
K963062 |
BECKMAN INSTRUMENTS, INC. |
IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2 |
12/13/1996 |
K082953 |
BIOKIT S.A. |
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 |
12/22/2008 |
K970881 |
BOEHRINGER MANNHEIM CORP. |
CEDIA DIGOXIN |
05/14/1997 |
K970883 |
BOEHRINGER MANNHEIM CORP. |
CEDIA DIGOXIN II |
05/21/1997 |
K973112 |
BOEHRINGER MANNHEIM CORP. |
ELECSYS DIGOXIN |
10/10/1997 |
K012301 |
DIAGNOSTIC PRODUCTS CORP. |
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) |
09/19/2001 |
K963835 |
DIAGNOSTIC REAGENTS, INC. |
DIGOXIN ENZYME IMMUNOASSAY |
12/10/1996 |
K983323 |
DIAGNOSTIC REAGENTS, INC. |
DIGOXIN IMMUNOASSAY |
11/12/1998 |
K011302 |
RANDOX LABORATORIES, LTD. |
RANDOX DIGOXIN |
07/02/2001 |
K102346 |
RANDOX LABORATORIES, LTD. |
RANDOX DIGOXIN ASSAY |
10/14/2011 |
K153301 |
ROCHE DIAGNOSTICS |
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II |
04/08/2016 |
K023058 |
SERADYN |
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM |
10/24/2002 |
K093441 |
SIEMENS HEALTHCARE DIAGNOSTICS |
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 |
04/07/2010 |
K193397 |
Siemens Healthcare Diagnostics, Inc. |
ADVIA Centaur« Digoxin assay |
07/16/2021 |
K972794 |
SIGMA DIAGNOSTICS, INC. |
DIGOXIN DG-II FPIA REAGENT SET |
07/31/1997 |
K011920 |
SYVA CO., DADE BEHRING, INC. |
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 |
07/02/2001 |