CDOClass I
Acid, Uric, Uricase (U.V.)
21 CFR 862.1775 / Clinical Chemistry
CDO is the FDA product code for Acid, Uric, Uricase (U.V.), a class I device type, regulated under 21 CFR 862.1775. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- CDO
- Device name
- Acid, Uric, Uricase (U.V.)
- Regulation
- 21 CFR 862.1775
- Device class
- Class I
- Review panel
- Clinical Chemistry
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 31
- Ingested recalls
- 1
Clearances, product code CDO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 3 |
| 1978 | 1 |
| 1979 | 2 |
| 1980 | 3 |
| 1981 | 2 |
| 1982 | 5 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 1990 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 3 |
| 1999 | 1 |
| 2004 | 1 |
Applicants with the most clearances
Product code CDO| Applicant | Clearances |
|---|---|
| Em Diagnostic Systems, Inc. | 4 |
| Abbott Medical | 2 |
| EMD Millipore Corporation | 2 |
| Sigma Diagnostics, Inc. | 2 |
| Worthington Biochemical Corp. | 2 |
| BD Becton Dickinson Vacutainer Systems Preanalytic | 1 |
| Biorent Diagnostic, Inc. | 1 |
| Biotrol, USA, Inc. | 1 |
| Boehringer Mannheim Corp. | 1 |
| Calbiochem-Behring Corp. | 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.
