DFH
- Product code
- DFH
- Device name
- Kappa, Antigen, Antiserum, Control
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.5550
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 63 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253358 | 2025-12-19 | Diazyme Laboratories, Inc. | Diazyme Human Kappa (k) Free Light Chain Assay; Diaz… | |
| K250549 | 2025-05-23 | The Binding Site Group , Ltd. | Optilite® Freelite Mx Kappa Free Kit; Optilite® Free… | |
| K231601 | 2024-02-23 | Sebia | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Contr… | |
| K231290 | 2024-01-24 | The Binding Site, Ltd. | Optilite® Freelite® Kappa Free Kit, Optilite® Freeli… |
Official FDA classification page: DFH
Classification and pathway per current FDA publications. Data from openFDA (CC0).