CDHClass I
Acid, Uric, Phosphotungstate Reduction
21 CFR 862.1775 / Clinical Chemistry
CDH is the FDA product code for Acid, Uric, Phosphotungstate Reduction, a class I device type, regulated under 21 CFR 862.1775. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- CDH
- Device name
- Acid, Uric, Phosphotungstate Reduction
- 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
- 15
- Ingested recalls
- 0
Clearances, product code CDH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 4 |
| 1979 | 3 |
| 1980 | 2 |
| 1981 | 2 |
| 1982 | 1 |
| 1984 | 1 |
| 1985 | 1 |
Applicants with the most clearances
Product code CDH| Applicant | Clearances |
|---|---|
| Volu Sol Medical Industries | 2 |
| American Monitor Corp. | 1 |
| BD Becton Dickinson Vacutainer Systems Preanalytic | 1 |
| Bio-Analytics Laboratories, Inc. | 1 |
| Diagnostic Solutions, Inc. | 1 |
| Dilab, Inc. | 1 |
| Fisher Scientific Company L.L.C. | 1 |
| Gamma Enterprises, Inc. | 1 |
| Icn Pharmaceuticals, Inc. | 1 |
| Mallinckrodt Critical Care | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code CDH.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
