JXMClass II
Enzyme Immunoassay, Benzodiazepine
21 CFR 862.3170 / Clinical Toxicology
JXM is the FDA product code for Enzyme Immunoassay, Benzodiazepine, a class II device type, regulated under 21 CFR 862.3170. As of , FDA records hold 90 510(k) clearances under this code, the most recent dated , and 81 recalls.
Classification record
- Product code
- JXM
- Device name
- Enzyme Immunoassay, Benzodiazepine
- Regulation
- 21 CFR 862.3170
- 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
- 90
- Ingested recalls
- 81
Clearances, product code JXM
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 1 |
| 1984 | 4 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 6 |
| 1988 | 3 |
| 1989 | 3 |
| 1990 | 2 |
| 1991 | 3 |
| 1992 | 2 |
| 1993 | 4 |
| 1994 | 3 |
| 1995 | 7 |
| 1996 | 4 |
| 1997 | 1 |
| 1998 | 6 |
| 1999 | 3 |
| 2000 | 5 |
| 2001 | 5 |
| 2002 | 3 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 4 |
| 2006 | 2 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code JXM| Applicant | Clearances |
|---|---|
| Abbott Medical | 8 |
| Microgenics Corporation | 7 |
| Roche Diagnostic Systems, Inc. | 7 |
| Siemens Healthcare Diagnostics Inc. | 6 |
| Healgen Scientific LLC | 4 |
| Princeton BioMeditech Corp. | 4 |
| Syva Co. | 4 |
| Syva Co. | 4 |
| E.I. Dupont de Nemours & Co., Inc. | 3 |
| Roche Diagnostics GmbH | 3 |
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.