CDPClass II
Radioimmunoassay, Total Triiodothyronine
21 CFR 862.1710 / Clinical Chemistry
CDP is the FDA product code for Radioimmunoassay, Total Triiodothyronine, a class II device type, regulated under 21 CFR 862.1710. As of , FDA records hold 144 510(k) clearances under this code, the most recent dated , and 20 recalls.
Classification record
- Product code
- CDP
- Device name
- Radioimmunoassay, Total Triiodothyronine
- Regulation
- 21 CFR 862.1710
- Device class
- Class II
- 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
- 144
- Ingested recalls
- 20
Clearances, product code CDP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 3 |
| 1977 | 13 |
| 1978 | 7 |
| 1979 | 8 |
| 1980 | 8 |
| 1981 | 9 |
| 1982 | 3 |
| 1983 | 7 |
| 1984 | 8 |
| 1985 | 3 |
| 1986 | 1 |
| 1987 | 6 |
| 1988 | 6 |
| 1989 | 6 |
| 1990 | 6 |
| 1991 | 5 |
| 1992 | 7 |
| 1993 | 4 |
| 1994 | 5 |
| 1995 | 1 |
| 1996 | 14 |
| 1997 | 5 |
| 1998 | 5 |
| 1999 | 3 |
| 2000 | 1 |
Applicants with the most clearances
Product code CDP| Applicant | Clearances |
|---|---|
| Abbott Medical | 13 |
| Amersham Corp. | 7 |
| Siemens Healthcare Diagnostics Inc. | 6 |
| Boehringer Mannheim Corp. | 4 |
| BD Becton Dickinson Vacutainer Systems Preanalytic | 3 |
| Bio-Rad Laboratories Inc. | 3 |
| E. R. Squibb & Sons, Inc. | 3 |
| G.D. Searle and Co. | 3 |
| IMMUNOTECH s.r.o. | 3 |
| Monobind, Inc. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Ireland Diagnostics Division
- Abbott Medical
- American Laboratory Products Company
- Beckman Coulter Ireland Inc
- Beijing Hotgen Biotech Co., Ltd.
- Boditech Med Inc.
- CTK Biotech, Inc.
- Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti
- Diagnostic Automation/ Cortez Diagnostics Inc.
- Diagnostics Biochem Canada, Inc.
- DIAMOND DIAGNOSTICS Inc
- DiaSorin Deutschland GmbH
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.
