Immpulse Digoxin Assay Reagents
FDA 510(k) K842571 · Aktis Corp.
510(k) numberK842571
Submission
- Device name
- Immpulse Digoxin Assay Reagents
- Applicant
- Aktis Corp.
Mchenry, IL, US - Received
- July 3, 1984
- Decision date
- August 16, 1984
- 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 |
|---|---|---|
| K842554 | Immpulse Cortisol Assay ReagentsCGR · Traditional | 08/12/1984SE |
Questions and answers
When was Immpulse Digoxin Assay Reagents cleared by the FDA?
Immpulse Digoxin Assay Reagents (K842571) received a 510(k) decision of Substantially Equivalent on August 16, 1984, 44 days after the submission was received.
What is the product code of K842571?
The FDA product code is KXT – Enzyme Immunoassay, Digoxin, a Class II (moderate risk) device regulated under 21 CFR 862.3320.