ORI

Levetiracetam Assay

Product code

ORI

Device name

Levetiracetam Assay

Device class

Class 2

21 CFR

21 CFR 862.3350

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)

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

FDA classification definition

For the quantitative determination of levetiracetam in human serum or plasma.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

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

Last three years. Most recent: 2024-02-27.

1 summaries are archived here for direct download.