LER
- Product code
- LER
- Device name
- Fluorescent Immunoassay, Theophylline
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.3880
- Medical specialty
- Clinical Toxicology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 15
Official FDA classification page: LER
Classification and pathway per current FDA publications. Data from openFDA (CC0).