Bayer Advia Digoxin Assay for the Integrated Module System
FDA 510(k) K033007 · Bayer Diagnostics Corp.
510(k) numberK033007
Submission
- Device name
- Bayer Advia Digoxin Assay for the Integrated Module System
- Applicant
- Bayer Diagnostics Corp.
Tarrytown, NY, US - Received
- September 26, 2003
- Decision date
- November 14, 2003
- 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 |
| 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 |
| 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 |
More from Randox Laboratories, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K033379 | Bayer Special Chemistry ControlsJJY · Abbreviated | 12/19/2003SE |
| K033380 | Bayer Special Chemistry CalibratorsJIX · Abbreviated | 12/16/2003SE |
| K031857 | Advia Chemistry ALPHA-1 Antitrypsin AssayDEM · Traditional | 09/04/2003SE |
| K022096 | Uric Acid Assay for the Advia Integrated Modular SystemKNK · Traditional | 03/18/2003SE |
| K030452 | Bayer Ligand Plus 1, 2, 3 ControlsJJY · Abbreviated | 03/03/2003SE |
| K023840 | Acid Phosphatase Assay for the Advia 1650CKB · Traditional | 01/07/2003SE |
| K023841 | Ammonia Assay for the Advia 1650JIF · Traditional | 12/24/2002SE |
| K022177 | Prostate Specific Antigen (Psa) Assay for the Advia Integrated Modular SystemLTJ · Traditional | 12/17/2002SE |
| K022329 | Ca 125 II Assay for the Bayer Advia Integrated Module SystemLTK · Traditional | 11/27/2002SE |
| K023184 | Ethanol Assay for the Bayer Advia Integrated Module SystemDIC · Traditional | 11/18/2002SE |
Questions and answers
When was Bayer Advia Digoxin Assay for the Integrated Module System cleared by the FDA?
Bayer Advia Digoxin Assay for the Integrated Module System (K033007) received a 510(k) decision of Substantially Equivalent on November 14, 2003, 49 days after the submission was received.
What is the product code of K033007?
The FDA product code is KXT – Enzyme Immunoassay, Digoxin, a Class II (moderate risk) device regulated under 21 CFR 862.3320.