MRG
- Product code
- MRG
- Device name
- System, Test, Vitamin D
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1825
- Medical specialty
- Clinical Chemistry
- 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)
- 46 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232587 | 2024-04-12 | Shenzhen New Industries Biomedical Eng | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemi | |
| K221817 | 2023-09-22 | Immunostics Inc., | ALFIS Vitamin D, ALFIS-3 Analyzer |
Official FDA classification page: MRG
Classification and pathway per current FDA publications. Data from openFDA (CC0).