LEHClass II
Radioimmunoassay, Vancomycin
21 CFR 862.3950 / Clinical Toxicology
LEH is the FDA product code for Radioimmunoassay, Vancomycin, a class II device type, regulated under 21 CFR 862.3950. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and 12 recalls.
Classification record
- Product code
- LEH
- Device name
- Radioimmunoassay, Vancomycin
- Regulation
- 21 CFR 862.3950
- 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
- 31
- Ingested recalls
- 12
Clearances, product code LEH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1982 | 2 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 2 |
| 1992 | 1 |
| 1994 | 1 |
| 1995 | 3 |
| 1996 | 3 |
| 1997 | 1 |
| 1998 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2005 | 2 |
| 2006 | 2 |
| 2008 | 1 |
| 2013 | 1 |
| 2016 | 2 |
| 2023 | 1 |
Applicants with the most clearances
Product code LEH| Applicant | Clearances |
|---|---|
| Siemens Healthcare Diagnostics Inc. | 5 |
| Abbott Medical | 4 |
| Biokit, S.A. | 2 |
| Innotron of Oregon, Inc. | 2 |
| Roche Diagnostic Systems, Inc. | 2 |
| American Diagnostic Corp. | 1 |
| Baxter Healthcare Corporation | 1 |
| Bayer Corp. | 1 |
| Ciba Corning Diagnostics Corp. | 1 |
| Dade Intl., Inc. | 1 |
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.