KXTClass II
Enzyme Immunoassay, Digoxin
21 CFR 862.3320 / Clinical Toxicology
KXT is the FDA product code for Enzyme Immunoassay, Digoxin, a class II device type, regulated under 21 CFR 862.3320. As of , FDA records hold 85 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- KXT
- Device name
- Enzyme Immunoassay, Digoxin
- Regulation
- 21 CFR 862.3320
- Device class
- Class II
- Review panel
- Clinical Toxicology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 85
- Ingested recalls
- 7
Clearances, product code KXT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 3 |
| 1980 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 7 |
| 1985 | 2 |
| 1986 | 5 |
| 1987 | 5 |
| 1988 | 3 |
| 1989 | 4 |
| 1990 | 3 |
| 1991 | 3 |
| 1992 | 4 |
| 1993 | 8 |
| 1994 | 6 |
| 1995 | 7 |
| 1996 | 2 |
| 1997 | 4 |
| 1998 | 4 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2016 | 1 |
| 2021 | 1 |
Applicants with the most clearances
Product code KXT| Applicant | Clearances |
|---|---|
| Microgenics Corporation | 9 |
| Abbott Medical | 5 |
| Siemens Healthcare Diagnostics Inc. | 5 |
| E.I. Dupont de Nemours & Co., Inc. | 5 |
| Boehringer Mannheim Corp. | 4 |
| Syva Co. | 4 |
| Instrumentation Laboratory Co. | 3 |
| Sigma Diagnostics, Inc. | 3 |
| Syva Co. | 3 |
| BD Becton Dickinson Vacutainer Systems Preanalytic | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.