DeviceClearance

Product code LFG— Clinical Toxicology

EMIT DESIPRAMINE ASSAY

Classification name
Radioimmunoassay, Tricyclic Antidepressant Drugs
Device class
Class 2
Regulation
21 CFR 862.3910
Advisory panel
Clinical Toxicology
Total cleared
21
First cleared
Most recent

FDA classification definition

“Intended to measure any of the tricyclic antidepressant drugs in serum or urine.”

— U.S. Food and Drug Administration, device classification record for product code LFG under 21 CFR 862.3910, via openFDA

Market context for product code LFG

FDA has cleared 21 devices under product code LFG between 1982 and 2015, filed by 10 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 LFG

Recent clearances under product code LFG

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