LCD

Enzyme Immunoassay, Gentamicin

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)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

37 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-07-09.

1 summaries are archived here for direct download.