Digoxin-Eia-Xt
FDA 510(k) K896863 · In Vitro Diagnostics, Inc.
510(k) numberK896863
Submission
- Device name
- Digoxin-Eia-Xt
- Applicant
- In Vitro Diagnostics, Inc.
Littleton, CO, US - Received
- December 6, 1989
- Decision date
- February 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KXT – Enzyme Immunoassay, Digoxin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code KXT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193397 | ADVIA Centaur® Digoxin assayKXT · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/16/2021SE |
| K153301 | Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIKXT · Traditional | Roche Diagnostics | 04/08/2016SE |
| K102346 | Randox Digoxin AssayKXT · Traditional | Randox Laboratories, Ltd. | 10/14/2011SE |
| K093441 | Dimension Vista Loci Digoxin Flex Reagent Cartridge (Digxn), Model K6435KXT · Traditional | Siemens Healthcare Diagnostics | 04/07/2010SE |
| K082953 | Architect Idigoxin and Architect Idigoxin Calibrators, Models 1P32-25 and IP32-01KXT · Traditional | Biokit, S.A. | 12/22/2008SE |
| K061249 | Axsym Digoxin IIIKXT · Special | Abbott Laboratories | 06/02/2006SE |
| K033007 | Bayer Advia Digoxin Assay for the Integrated Module SystemKXT · Traditional | Bayer Diagnostics Corp. | 11/14/2003SE |
| K023058 | QMS Digoxin Reagent System on the Abbott Aeroset SystemKXT · Traditional | Seradyn | 10/24/2002SE |
| K012301 | Immulite 2000 Digoxin, Models L2KDI2 (200 Tests) and L2KDI6 (600 Tests)KXT · Traditional | Diagnostic Products Corp. | 09/19/2001SE |
| K011920 | Emit 2000 Digoxin Assay, Model OSR4H229KXT · Special | Syva Co., Dade Behring, Inc. | 07/02/2001SE |
More from Syva Co., Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896867 | Thyroid Stimulating Hormone-Eia-XtJLW · Traditional | 02/23/1990SE |
| K896866 | Luteinizing Hormone-Eia-XtCEP · Traditional | 02/13/1990SE |
| K896865 | Vitro T4-EIA-XTKLI · Traditional | 01/30/1990SE |
| K896925 | T Uptake Enzyme Immunoassay Crimped Tube KitKHQ · Traditional | 01/18/1990SE |
| K896864 | Follicle Stimulating Hormone-Eia-XtCGJ · Traditional | 01/11/1990SE |
| K873832 | Reagents for Use on Contraves DC300, DC500, AL801KRZ · Traditional | 11/23/1987SE |
| K871188 | Lithium Internal Standard 1500 Meq/L #60086JIS · Traditional | 05/28/1987SE |
| K871187 | Lithium Internal Standard 3000 Meq/L #60084JIS · Traditional | 05/28/1987SE |
| K871186 | Cesium Diluent 1.5 Mmol Cs/L #60087JIS · Traditional | 05/28/1987SE |
| K871185 | Lithium Internal Standard 1 Meq/L #60085JIS · Traditional | 05/28/1987SE |
Questions and answers
When was Digoxin-Eia-Xt cleared by the FDA?
Digoxin-Eia-Xt (K896863) received a 510(k) decision of Substantially Equivalent on February 13, 1990, 69 days after the submission was received.
What is the product code of K896863?
The FDA product code is KXT – Enzyme Immunoassay, Digoxin, a Class II (moderate risk) device regulated under 21 CFR 862.3320.