CGR
- Product code
- CGR
- Device name
- Radioimmunoassay, Cortisol
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1205
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 84
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242190 | 2025-03-05 | Beckman Coulter, Inc. | Access Cortisol; DxC 500i Clinical Analyzer |
Official FDA classification page: CGR
Classification and pathway per current FDA publications. Data from openFDA (CC0).