KLP
- Product code
- KLP
- Device name
- Amikacin Serum Assay
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.3035
- Medical specialty
- Clinical Toxicology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (all years, FDA)
- 4 (all years; only the last 3 years are listed here)
Official FDA classification page: KLP
Classification and pathway per current FDA publications. Data from openFDA (CC0).