KXT — Enzyme Immunoassay, Digoxin Class II
FDA product code KXT covers "Enzyme Immunoassay, Digoxin", a Class II medical device regulated under 21 CFR 862.3320. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KXT
- Device Class
- Class II
- Regulation Number
- 862.3320
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K193397 | siemens healthcare diagnostics | ADVIA Centaur® Digoxin assay | July 16, 2021 |
| K153301 | roche diagnostics | Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II | April 8, 2016 |
| K102346 | randox laboratories | RANDOX DIGOXIN ASSAY | October 14, 2011 |
| K093441 | siemens healthcare diagnostics | DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 | April 7, 2010 |
| K082953 | biokit | ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-0 | December 22, 2008 |
| K061249 | abbott laboratories | AXSYM DIGOXIN III | June 2, 2006 |
| K033007 | bayer diagnostics | BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM | November 14, 2003 |
| K023058 | seradyn | QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM | October 24, 2002 |
| K012301 | diagnostic products | IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) | September 19, 2001 |
| K011302 | randox laboratories | RANDOX DIGOXIN | July 2, 2001 |
| K011920 | syva co., dade behring | EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 | July 2, 2001 |
| K983323 | diagnostic reagents | DIGOXIN IMMUNOASSAY | November 12, 1998 |
| K983151 | beckman coulter | IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT | November 5, 1998 |
| K982935 | beckman coulter | SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR | October 14, 1998 |
| K980521 | bayer | DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS | April 2, 1998 |
| K973112 | boehringer mannheim | ELECSYS DIGOXIN | October 10, 1997 |
| K972794 | sigma diagnostics | DIGOXIN DG-II FPIA REAGENT SET | July 31, 1997 |
| K970883 | boehringer mannheim | CEDIA DIGOXIN II | May 21, 1997 |
| K970881 | boehringer mannheim | CEDIA DIGOXIN | May 14, 1997 |
| K963062 | beckman instruments | IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2 | December 13, 1996 |