MOI
- Product code
- MOI
- Device name
- System, Test, Immunological, Antigen, Tumor
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.6010
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 28
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240403 | 2024-05-09 | Beckman Coulter, Inc. | Access BR Monitor | |
| K233946 | 2024-03-13 | Siemens Healthcare Diagnostics Product | IMMULITE® 2000 BR-MA |
Official FDA classification page: MOI
Classification and pathway per current FDA publications. Data from openFDA (CC0).