CEW
- Product code
- CEW
- Device name
- Radioimmunoassay, Parathyroid Hormone
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1545
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 86 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K231927 | 2024-03-22 | Roche Diagnostics | Elecsys PTH , Elecsys PTH STAT | |
| K232791 | 2024-03-01 | Beckman Coulter, Inc. | Access Intact PTH |
Official FDA classification page: CEW
Classification and pathway per current FDA publications. Data from openFDA (CC0).