DCK
- Product code
- DCK
- Device name
- C-Reactive Protein, Antigen, Antiserum, And Control
- 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)
- 126
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242170 | 2025-04-18 | Kamiya Biomedical Company, LLC | K-ASSAY CRP (Ver.2) |
Official FDA classification page: DCK
Classification and pathway per current FDA publications. Data from openFDA (CC0).