DeviceClearance

Product code ORH— Clinical Toxicology

ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL

Classification name
Lamotrigine 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 lamotrigine in human serum or plasma on automated clinical chemistry analyzers.”

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

Market context for product code ORH

FDA has cleared 2 devices under product code ORH between 2007 and 2010, filed by 2 applicant companies. 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 ORH

Recent clearances under product code ORH

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