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 Syva Co., Healgen Scientific, LLC and E.I. Dupont DE Nemours & Co., Inc..

21
Total
21
Cleared
72d
Avg days
1982
Since

FDA 510(k) Cleared Radioimmunoassay, Tricyclic Antidepressant Drugs Devices (Product Code LFG)

21 devices
1–21 of 21
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
Cleared Mar 20, 1987
EMIT NORTRIPTYLINE ASSAY
K870823
Syva Co.
Toxicology · 17d
Cleared May 02, 1986
EMIT DESIPRAMINE ASSAY
K861155
Syva Co.
Toxicology · 35d
Cleared Aug 12, 1985
TD TRICYCLIC ANTIDEPRESSANTS
K853113
Abbott Laboratories
Toxicology · 19d
Cleared Jun 28, 1985
EMIT AMITRIPTYLINE ASSAY
K844950
Syva Co.
Toxicology · 190d
Cleared Jun 28, 1985
EMIT IMIPRAMINE ASSAY
K844951
Syva Co.
Toxicology · 190d
Cleared Jun 28, 1985
EMIT NORTRIPTYLINE ASSAY
K844952
Syva Co.
Toxicology · 190d
Cleared Jun 28, 1985
EMIT DESIPRAMINE ASSAY
K844953
Syva Co.
Toxicology · 190d
Cleared May 02, 1984
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES
K841532
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 16d
Cleared Mar 19, 1984
EMIT ST SERUM TRICYCLIC ANTIDEPRESSANT
K834550
Syva Co.
Toxicology · 83d
Cleared Aug 11, 1983
EMIT SERUM TRICYCLIC ANTIDEPRESSENT
K831978
Syva Co.
Chemistry · 52d
Cleared Jul 02, 1982
EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY
K821743
Syva Co.
Toxicology · 18d

About Product Code LFG - Regulatory Context