CDD
- Product code
- CDD
- Device name
- Radioassay, Vitamin B12
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1810
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 78
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K233541 | 2024-07-31 | Axis-Shield Diagnostics, Ltd. | ARCHITECT Active-B12 (Holotranscobalamin) |
Official FDA classification page: CDD
Classification and pathway per current FDA publications. Data from openFDA (CC0).