CDZ
- Product code
- CDZ
- Device name
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Device class
- Class 1
- 21 CFR
- 21 CFR 862.1680
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 89 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252728 | 2026-04-15 | Immunodiagnostic Systems Limited | IDS-iSYS Total Testosterone | |
| K240865 | 2024-10-23 | Immunodiagnostic Systems Limited | IDS-iSYS Free Testosterone | |
| K233480 | 2024-02-08 | Beckman Coulter, Inc. | Access SHBG |
Official FDA classification page: CDZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).