Enzyme-Test Digoxin
FDA 510(k) K823199 · Icl Scientific
510(k) numberK823199
Submission
- Device name
- Enzyme-Test Digoxin
- Applicant
- Icl Scientific
Mchenry, IL, US - Received
- October 26, 1982
- Decision date
- November 29, 1982
- 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 |
|---|---|---|
| K883942 | Hycor Sentry Drugs of Abuse Urine ControlJJY · Traditional | 11/10/1988SE |
| K843565 | Kova Trol I,Ii, III Human Urine-DriedJJW · Traditional | 10/05/1984SE |
| K833761 | Therapeutic Drug ControlDKB · Traditional | 01/13/1984SE |
| K832823 | Enzymune-Test TSHJLW · Traditional | 10/14/1983SE |
| K831383 | Event-Test SlideJHJ · Traditional | 06/22/1983SE |
| K822777 | Therapeutic Drug ControlDIF · Traditional | 10/08/1982SE |
| K822346 | Histimune Enzyme-Ana TestLJM · Traditional | 10/08/1982SE |
| K822465 | Enzymune System IJJE · Traditional | 09/14/1982SE |
| K821374 | Enzymune-Test InsulinCFP · Traditional | 05/28/1982SE |
| K821097 | Systemic Lupus Erythermatosus Anti-N-Dna · Traditional | 05/05/1982SE |
Questions and answers
When was Enzyme-Test Digoxin cleared by the FDA?
Enzyme-Test Digoxin (K823199) received a 510(k) decision of Substantially Equivalent on November 29, 1982, 34 days after the submission was received.
What is the product code of K823199?
The FDA product code is KXT – Enzyme Immunoassay, Digoxin, a Class II (moderate risk) device regulated under 21 CFR 862.3320.