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., Guangzhou Wondfo Biotech Co., Ltd. and ACON Laboratories, 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 Dec 18, 2014
CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine
K142609
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 93d
Cleared Sep 09, 2011
WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST
K112395
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 21d
Cleared Jul 17, 2002
ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
K021526
ACON Laboratories, Inc.
Chemistry · 68d
Cleared Mar 13, 1998
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
K980249
Princeton BioMeditech Corp.
Toxicology · 49d
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