LFG

Radioimmunoassay, Tricyclic Antidepressant Drugs

Product code: LFG
Device name: Radioimmunoassay, Tricyclic Antidepressant Drugs
Device class: Class 2
21 CFR: 21 CFR 862.3910
Medical specialty: Clinical Toxicology
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (all years, FDA): 21 (all years; only the last 3 years are listed here)

FDA classification definition

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

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

Official FDA classification page: LFG

Classification and pathway per current FDA publications. Data from openFDA (CC0).