DFC
- Product code
- DFC
- Device name
- Lipoprotein, Low-Density, Antigen, Antiserum, Control
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.5600
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 43 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253069 | 2026-06-16 | Diazyme Laboratories, Inc. | Lipoprotein (a) Molarity Assay | |
| K241220 | 2025-01-24 | Roche Diagnostics Operations | Tina-quant Lipoprotein(a) Gen.2 Molarity |
Official FDA classification page: DFC
Classification and pathway per current FDA publications. Data from openFDA (CC0).