Dimension Vista Loci Digoxin Flex Reagent Cartridge (Digxn), Model K6435
FDA 510(k) K093441 · Siemens Healthcare Diagnostics
510(k) numberK093441
Submission
- Device name
- Dimension Vista Loci Digoxin Flex Reagent Cartridge (Digxn), Model K6435
- Applicant
- Siemens Healthcare Diagnostics
Newark, DE, US - Received
- November 5, 2009
- Decision date
- April 7, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K011302 | Randox DigoxinKXT · Traditional | Randox Laboratories, Ltd. | 07/02/2001SE |
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Questions and answers
When was Dimension Vista Loci Digoxin Flex Reagent Cartridge (Digxn), Model K6435 cleared by the FDA?
Dimension Vista Loci Digoxin Flex Reagent Cartridge (Digxn), Model K6435 (K093441) received a 510(k) decision of Substantially Equivalent on April 7, 2010, 153 days after the submission was received.
What is the product code of K093441?
The FDA product code is KXT – Enzyme Immunoassay, Digoxin, a Class II (moderate risk) device regulated under 21 CFR 862.3320.