DIOClass II
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
21 CFR 862.3250 / Clinical Toxicology
DIO is the FDA product code for Enzyme Immunoassay, Cocaine And Cocaine Metabolites, a class II device type, regulated under 21 CFR 862.3250. As of , FDA records hold 145 510(k) clearances under this code, the most recent dated , and 23 recalls.
Classification record
- Product code
- DIO
- Device name
- Enzyme Immunoassay, Cocaine And Cocaine Metabolites
- Regulation
- 21 CFR 862.3250
- 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
- 145
- Ingested recalls
- 23
Clearances, product code DIO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 3 |
| 1985 | 1 |
| 1987 | 8 |
| 1988 | 4 |
| 1989 | 4 |
| 1990 | 3 |
| 1991 | 4 |
| 1992 | 1 |
| 1993 | 3 |
| 1994 | 5 |
| 1995 | 11 |
| 1996 | 3 |
| 1997 | 5 |
| 1998 | 10 |
| 1999 | 7 |
| 2000 | 8 |
| 2001 | 10 |
| 2002 | 11 |
| 2003 | 5 |
| 2004 | 4 |
| 2005 | 3 |
| 2006 | 5 |
| 2009 | 1 |
| 2011 | 5 |
| 2012 | 5 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 2 |
| 2016 | 3 |
| 2017 | 3 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
Applicants with the most clearances
Product code DIO| Applicant | Clearances |
|---|---|
| Roche Diagnostic Systems, Inc. | 9 |
| Siemens Healthcare Diagnostics Inc. | 8 |
| Princeton BioMeditech Corp. | 7 |
| Abbott Medical | 6 |
| Microgenics Corporation | 6 |
| Branan Medical Corp. | 5 |
| American Bio Medica Corp. | 4 |
| Guangzhou Wondfo Biotech Co., Ltd. | 4 |
| Lin-Zhi International Inc | 4 |
| OraSure Technologies, Inc. | 4 |
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.