DCN
- Product code
- DCN
- Device name
- System, Test, C-Reactive Protein
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.5270
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 70
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232624 | 2023-11-27 | Siemens Healthcare Diagnostic Products | CardioPhase® hsCRP |
Official FDA classification page: DCN
Classification and pathway per current FDA publications. Data from openFDA (CC0).