DeviceClearance

Product code ORI— Clinical Toxicology

ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00

Classification name
Levetiracetam Assay
Device class
Class 2
Regulation
21 CFR 862.3350
Advisory panel
Clinical Toxicology
Total cleared
2
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code ORI under 21 CFR 862.3350, via openFDA

Market context for product code ORI

FDA has cleared 2 devices under product code ORI between 2009 and 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code ORI

Recent clearances under product code ORI

Data sourced from openFDA. This site is unofficial and independent of the FDA.