LCD · Class II · 21 CFR 862.3450

FDA Product Code LCD: Enzyme Immunoassay, Gentamicin

Leading manufacturers include Abbott Laboratories.

37
Total
37
Cleared
69d
Avg days
1980
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 239d recently vs 64d historically

FDA 510(k) Cleared Enzyme Immunoassay, Gentamicin Devices (Product Code LCD)

37 devices
1–24 of 37
Cleared Jul 09, 2025
ARCHITECT iGentamicin
K243500
Abbott Laboratories
Toxicology · 239d

About Product Code LCD - Regulatory Context

510(k) Submission Activity

37 total 510(k) submissions under product code LCD since 1980, with 37 receiving FDA clearance (average review time: 69 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under LCD have taken an average of 239 days to reach a decision - up from 64 days historically. Manufacturers should account for longer review timelines in current project planning.

LCD devices are reviewed by the Toxicology panel. Browse all Toxicology devices →