Product code LFM
- Device name
- Enzyme Immunoassay, Digitoxin
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3300
- 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 |
|---|---|---|---|
| K062024 | DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2006-07-28 |
| K012112 | RANDOX DIGITOXIN | Randox Laboratories, Ltd. | 2002-01-11 |
| K990251 | DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 | Dade Behring, Inc. | 1999-03-31 |
| K970546 | ACS DIGITOXIN | Chiron Diagnostics Corp. | 1997-07-14 |
| K963158 | ABBOTT AXSYM DIGITOXIN (MODIFY) | Abbott Laboratories | 1996-09-10 |
| K954420 | AXSYM DIGITOXIN | Abbott Laboratories | 1995-12-29 |
| K951631 | DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS | Bayer Corp. | 1995-06-09 |
| K943235 | IMMULITE DIGITOXIN | Diagnostic Products Corp. | 1994-10-27 |
| K942610 | KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) | Eastman Kodak Company | 1994-10-20 |
| K942619 | EMIT 2000 DIGOXIN ASSAY/CALIBRATORS | Syva Co. | 1994-09-20 |
| K915465 | DIGITOXIN FPIA REAGENT SET | Sigma Diagnostics, Inc. | 1992-01-27 |
| K913187 | INNOFLUOR(TM) DIGITOXIN REAGENT SET | Intl. Bioclinical, Inc. | 1991-09-23 |
| K913240 | DIGITOXIN (FPIA) KIT | Tudor Laboratories, Inc. | 1991-09-06 |
| K900013 | MILENIA (TM) DIGITOXIN | Diagnostic Products Corp. | 1990-03-09 |
| K896021 | CEDIA DIGITOXIN ASSAY | Microgenics Corp. | 1989-11-08 |
| K891094 | ACA(R) DIGITOXIN (DGTX) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1989-04-26 |
| K862067 | STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | 1986-06-16 |
| K842280 | TDX DIGITOXIN | Abbott Laboratories | 1984-08-16 |
| K842578 | SOPHEIA/MP DIGITOXIN EIA KIT | Diagnostic Products Corp. | 1984-08-12 |
| K830035 | SOPHEIA DIGITOXIN EIA KIT & COMPONENTS | Diagnostic Products Corp. | 1983-01-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414961262 | IMMULITE 2000 Sytems Digitoxin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-08-05 |
| 00630414963846 | IMMULITE/IMMULITE 1000 Digitoxin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-08-05 |
| 00630414598772 | Atellica IM Dgtn | Siemens Healthcare Diagnostics Inc. | 2018-02-06 |
| 00630414598789 | Atellica IM Dgtn | Siemens Healthcare Diagnostics Inc. | 2018-02-06 |
| 00842768005510 | Dimension® Flex® reagent cartridge DGTX | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768033315 | Dimension Vista® Flex® reagent cartridge DGTX | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414203935 | ADVIA Centaur® DGTN | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414207414 | ADVIA Centaur® DGTN +Z | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00884883005648 | CEDIA Digitoxin Assay | Microgenics Corporation | 2016-09-12 |
| 10758750004782 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-26 |