LCD
- Product code
- LCD
- Device name
- Enzyme Immunoassay, Gentamicin
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.3450
- Medical specialty
- Clinical Toxicology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 37
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243500 | 2025-07-09 | Abbott Laboratories | ARCHITECT iGentamicin |
Official FDA classification page: LCD
Classification and pathway per current FDA publications. Data from openFDA (CC0).