MLE
- Product code
- MLE
- Device name
- Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.5110
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
Official FDA classification page: MLE
Classification and pathway per current FDA publications. Data from openFDA (CC0).