DeviceClearance

Product code LEG— Clinical Toxicology

EMIT VALPROIC ACID ASSAY

Classification name
Enzyme Immunoassay, Valproic Acid
Device class
Class 2
Regulation
21 CFR 862.3645
Advisory panel
Clinical Toxicology
Total cleared
35
First cleared
Most recent

Market context for product code LEG

FDA has cleared 35 devices under product code LEG between 1980 and 2009, filed by 24 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

last 15 years

Top applicants under product code LEG

Recent clearances under product code LEG

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