Panels › Clinical Toxicology › Product code KXT · Class 2
Enzyme Immunoassay, Digoxin
Regulation 862.3320
0510(k)s in 12 months (85 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in KXT
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 16, 2021 | K193397 | ADVIA Centaur® Digoxin assay Siemens Healthcare Diagnostics, Inc. | KXT |
| Apr 8, 2016 | K153301 | Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II Roche Diagnostics | KXT |
| Oct 14, 2011 | K102346 | RANDOX DIGOXIN ASSAY Randox Laboratories, Ltd., GB | KXT |
| Apr 7, 2010 | K093441 | DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 Siemens Healthcare Diagnostics | KXT |
| Dec 22, 2008 | K082953 | ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 Biokit, S.A., ES | KXT |
| Jun 2, 2006 | K061249 | AXSYM DIGOXIN III Abbott Laboratories | KXT |
| Nov 14, 2003 | K033007 | BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM Bayer Diagnostics Corp. | KXT |
| Oct 24, 2002 | K023058 | QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM Seradyn | KXT |
| Sep 19, 2001 | K012301 | IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) Diagnostic Products Corp. | KXT |
| Jul 2, 2001 | K011920 | EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 Syva Co., Dade Behring, Inc. | KXT |
| Jul 2, 2001 | K011302 | RANDOX DIGOXIN Randox Laboratories, Ltd., IE | KXT |
| Nov 12, 1998 | K983323 | DIGOXIN IMMUNOASSAY Diagnostic Reagents, Inc. | KXT |
| Nov 5, 1998 | K983151 | IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT Beckman Coulter, Inc. | KXT |
| Oct 14, 1998 | K982935 | SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR Beckman Coulter, Inc. | KXT |
| Apr 2, 1998 | K980521 | DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS Bayer Corp. | KXT |
| Oct 10, 1997 | K973112 | ELECSYS DIGOXIN Boehringer Mannheim Corp. | KXT |
| Jul 31, 1997 | K972794 | DIGOXIN DG-II FPIA REAGENT SET Sigma Diagnostics, Inc. | KXT |
| May 21, 1997 | K970883 | CEDIA DIGOXIN II Boehringer Mannheim Corp. | KXT |
| May 14, 1997 | K970881 | CEDIA DIGOXIN Boehringer Mannheim Corp. | KXT |
| Dec 13, 1996 | K963062 | IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2 Beckman Instruments, Inc. | KXT |
| Dec 10, 1996 | K963835 | DIGOXIN ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | KXT |
| Sep 25, 1995 | K953718 | AXSYM DIGOXIN II Abbott Laboratories | KXT |
| Jul 19, 1995 | K952079 | IMX DIGOXIN Abbott Laboratories | KXT |
| Jun 9, 1995 | K951391 | IL TEST DIGOXIN, PN 181761-00 Instrumentation Laboratory CO | KXT |
| Jun 1, 1995 | K951755 | EMIT 2000 DIGOXIN ASSAY Syva Co. | KXT |
| Jun 1, 1995 | K951441 | DUPONT ACA DIGOXIN (DGN A) METHOD E.I. Dupont DE Nemours & Co., Inc. | KXT |
| Apr 10, 1995 | K943983 | IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS Instrumentation Laboratory CO | KXT |
| Feb 22, 1995 | K946153 | DIGOXIN FLEX(TM) REAGENT CARTRIDGE E.I. Dupont DE Nemours & Co., Inc. | KXT |
| Dec 19, 1994 | K944506 | AXSYM DIGOXIN Abbott Laboratories | KXT |
| Nov 15, 1994 | K943500 | EMIT 2000 DIGOXIN ASSAY Syva Co. | KXT |
| Jul 13, 1994 | K940569 | DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET Sigma Diagnostics, Inc. | KXT |
| Jun 13, 1994 | K941255 | CEDIA DIGOXIN PLUS ASSAY Microgenics Corp. | KXT |
| May 3, 1994 | K940267 | ACE CLINICAL CHEMISTRY SYSTEM Schiapparelli Biosystems, Inc. | KXT |
| Apr 6, 1994 | K934135 | EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION Syva Co. | KXT |
| Dec 29, 1993 | K934168 | CEDIA DIGOXIN PLUS ASSAY Microgenics Corp. | KXT |
| Nov 15, 1993 | K932732 | ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN) Dupont Medical Products | KXT |
| Sep 10, 1993 | K932250 | VIDAS DIGOXIN (DIG) Biomerieux Vitek, Inc. | KXT |
| Aug 5, 1993 | K931123 | DIGOXIN TEST SYSTEM, KXT TX Syva Co. | KXT |
| Jun 7, 1993 | K931213 | ACS DIGOXIN IMMUNOASSAY Ciba Corning Diagnostics Corp. | KXT |
| Mar 10, 1993 | K930162 | ACA DIGOXIN ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. | KXT |
| Jan 13, 1993 | K925802 | ACCESS DIGOXIN ASSAY Bio-Rad Laboratories, Inc. | KXT |
| Jan 13, 1993 | K924504 | FAST DIGOXIN TEST SYSTEM Diatron Corp. | KXT |
| Dec 17, 1992 | K924594 | DELFIA DIGOXIN KIT Wallac OY, FI | KXT |
| Sep 15, 1992 | K923853 | CEDIA DIGOXIN PLUS ASSAY Microgenics Corp. | KXT |
| Mar 2, 1992 | K920214 | CEDIA DIGOXIN ASSAY (MODIFICATION) Microgenics Corp. | KXT |
| Jan 17, 1992 | K915602 | SRI DIGOXIN ENZYME IMMUNOASSAY Serono-Baker Diagnostics, Inc. | KXT |
| Nov 29, 1991 | K914151 | IL TEST(TM DIGOXIN Instrumentation Laboratory CO | KXT |
| May 15, 1991 | K911941 | CEDIA(R) DIGOXIN R' ASSAY Microgenics Corp. | KXT |
| Mar 21, 1991 | K910642 | CEDIA(R) DIGOXIN SC ASSAY Microgenics Corp. | KXT |
| Jun 26, 1990 | K901547 | OPUS(TM) DIGOXIN TEST SYSTEM Pb Diagnostic Systems, Inc. | KXT |
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