LFG · Class II · 21 CFR 862.3910

FDA Product Code LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs

Intended To Measure Any Of The Tricyclic Antidepressant Drugs In Serum Or Urine.

Leading manufacturers include Healgen Scientific, LLC.

1
Total
1
Cleared
90d
Avg days
2015
Since

List of Radioimmunoassay, Tricyclic Antidepressant Drugs devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Aug 18, 2015
Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
K151348
Healgen Scientific, LLC
Toxicology · 90d

How to use this database

This page lists all FDA 510(k) submissions for Radioimmunoassay, Tricyclic Antidepressant Drugs devices (product code LFG). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Toxicology FDA review panel. Browse all Toxicology devices →