510(k) K102346
- Device
- RANDOX DIGOXIN ASSAY
- Applicant
- RANDOX LABORATORIES, LTD.
- 510(k) number
- K102346
- Product code
- KXT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-10-14
- Date received
- 2010-08-19
- Regulation
- 862.3320
- Classification name
- Enzyme Immunoassay, Digoxin
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAULINE ARMSTRONG
- Address
- 55 Diamond Rd. Crumlin GB BT29 4QY BT29 4QY
FDA Registration Numbers#
- 3004192065
- 3010939897
- 2517506
- 2432235
- 3005333358
- 3006198300
- 3002806944
- 3004493545
- 3002809144
- 3010825766
- 9610126
- 8020888
- 3003795116
- 1036362
- 3002637618
- 2020726
- 2050012
- 2122870
- 3003561301
- 9610529
- 9610746
- 2050010
- 1219913
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KXT #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
Decision Summary