DDR
- Product code
- DDR
- Device name
- Myoglobin, Antigen, Antiserum, Control
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.5680
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 46
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K231832 | 2023-09-18 | Beckman Coulter, Inc. | Access Myoglobin |
Official FDA classification page: DDR
Classification and pathway per current FDA publications. Data from openFDA (CC0).