CFN
- Product code
- CFN
- Device name
- Method, Nephelometric, Immunoglobulins (G, A, M)
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.5510
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 61 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K233663 | 2023-12-13 | Siemens Healthcare Diagnostics Product… | N Antisera to Human Immunoglobulins (IgG, IgA, and I… |
Official FDA classification page: CFN
Classification and pathway per current FDA publications. Data from openFDA (CC0).