Product code KXT
- Device name
- Enzyme Immunoassay, Digoxin
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3320
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193397 | ADVIA Centaur® Digoxin assay | Siemens Healthcare Diagnostics, Inc. | 2021-07-16 |
| K153301 | Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II | Roche Diagnostics | 2016-04-08 |
| K102346 | RANDOX DIGOXIN ASSAY | Randox Laboratories, Ltd. | 2011-10-14 |
| K093441 | DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 | Siemens Healthcare Diagnostics | 2010-04-07 |
| K082953 | ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 | Biokit, S.A. | 2008-12-22 |
| K061249 | AXSYM DIGOXIN III | Abbott Laboratories | 2006-06-02 |
| K033007 | BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM | Bayer Diagnostics Corp. | 2003-11-14 |
| K023058 | QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM | Seradyn | 2002-10-24 |
| K012301 | IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) | Diagnostic Products Corp. | 2001-09-19 |
| K011920 | EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 | Syva Co., Dade Behring, Inc. | 2001-07-02 |
| K011302 | RANDOX DIGOXIN | Randox Laboratories, Ltd. | 2001-07-02 |
| K983323 | DIGOXIN IMMUNOASSAY | Diagnostic Reagents, Inc. | 1998-11-12 |
| K983151 | IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT | Beckman Coulter, Inc. | 1998-11-05 |
| K982935 | SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR | Beckman Coulter, Inc. | 1998-10-14 |
| K980521 | DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS | Bayer Corp. | 1998-04-02 |
| K973112 | ELECSYS DIGOXIN | Boehringer Mannheim Corp. | 1997-10-10 |
| K972794 | DIGOXIN DG-II FPIA REAGENT SET | Sigma Diagnostics, Inc. | 1997-07-31 |
| K970883 | CEDIA DIGOXIN II | Boehringer Mannheim Corp. | 1997-05-21 |
| K970881 | CEDIA DIGOXIN | Boehringer Mannheim Corp. | 1997-05-14 |
| K963062 | IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2 | Beckman Instruments, Inc. | 1996-12-13 |
| K963835 | DIGOXIN ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1996-12-10 |
| K953718 | AXSYM DIGOXIN II | Abbott Laboratories | 1995-09-25 |
| K952079 | IMX DIGOXIN | Abbott Laboratories | 1995-07-19 |
| K951391 | IL TEST DIGOXIN, PN 181761-00 | Instrumentation Laboratory CO | 1995-06-09 |
| K951441 | DUPONT ACA DIGOXIN (DGN A) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1995-06-01 |
| K951755 | EMIT 2000 DIGOXIN ASSAY | Syva Co. | 1995-06-01 |
| K943983 | IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS | Instrumentation Laboratory CO | 1995-04-10 |
| K946153 | DIGOXIN FLEX(TM) REAGENT CARTRIDGE | E.I. Dupont DE Nemours & Co., Inc. | 1995-02-22 |
| K944506 | AXSYM DIGOXIN | Abbott Laboratories | 1994-12-19 |
| K943500 | EMIT 2000 DIGOXIN ASSAY | Syva Co. | 1994-11-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336121214 | ONLINE TDM Digoxin | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740155988 | ARCHITECT | Abbott GmbH | 2020-03-03 |
| 00630414598826 | Atellica IM Dig | Siemens Healthcare Diagnostics Inc. | 2018-02-06 |
| 00630414598819 | Atellica IM Dig | Siemens Healthcare Diagnostics Inc. | 2018-02-06 |
| 00630414595863 | Atellica CH Dgn | Siemens Healthcare Diagnostics Inc. | 2017-12-19 |
| 04015630940400 | Elecsys Digoxin | Roche Diagnostics GmbH | 2017-04-21 |
| 04015630995127 | Tina-quant Digoxin | Roche Diagnostics GmbH | 2016-12-06 |
| 00884883011434 | DRI Digoxin Assay | Microgenics Corporation | 2016-09-26 |
| 00842768028335 | Dimension Vista® Flex® reagent cartridge DIGXN | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768023255 | Emit® 2000 Digoxin Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768005503 | Dimension® Flex® reagent cartridge DGNA | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768000973 | Syva® Emit® 2000 Digoxin Calibrators | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768000966 | Syva® Emit® 2000 Digoxin Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 05055273206425 | DG | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 00630414177410 | ADVIA Centaur® DIG | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414177427 | ADVIA Centaur® DIG +B | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414470375 | ADVIA® Chemistry DIG Digoxin Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414961286 | IMMULITE® 2000 Systems DGX Digoxin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414963860 | IMMULITE®/IMMULITE® 1000 Systems DIG Digoxin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 04015630911646 | Cobas Elecsys AntiTPO | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630946761 | Elecsys Digoxin Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630915682 | Digoxin | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630911639 | Elecsys Digoxin Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 00884883001206 | DRI Digoxin Assay | Microgenics Corporation | 2016-09-12 |
| 15099590225797 | Access Digoxin | Beckman Coulter, Inc. | 2016-09-09 |
| 15099590225780 | Access Digoxin Calibrators | Beckman Coulter, Inc. | 2016-09-09 |
| 15099590225766 | Access Digoxin Calibrator S0 | Beckman Coulter, Inc. | 2016-09-09 |
| 15099590232092 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 00380740000240 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740001759 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |