ClearanceBrief
Panels › Clinical Toxicology › Product code LFG · Class 2

Radioimmunoassay, Tricyclic Antidepressant Drugs

Regulation 862.3910

0510(k)s in 12 months (21 all time)
1recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in LFG

Decided510(k)Device and applicantCode
Aug 18, 2015K151348Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card),
Healgen Scientific,, LLC
LFG
Dec 18, 2014K142609CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine
Guangzhou Wondfo Biotech Co., Ltd., CN
LFG
Sep 9, 2011K112395WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST
Guangzhou Wondfo Biotech Co., Ltd.
LFG
Sep 20, 2007K072062UCP MULTIPLE DRUG SCREEN TEST CUPS
Ucp Biosciences, Inc.
LFG
Aug 21, 2006K061457UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS
Ucp Biosciences, Inc.
LFG
Jul 17, 2002K021526ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
ACON Laboratories, Inc.
LFG
Jun 8, 2001K011545VERDICT -II TCA, VERDICT-II MTD
Medtox Diagnostics, Inc.
LFG
Mar 13, 1998K980249ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
Princeton BioMeditech Corp.
LFG
Mar 20, 1987K870823EMIT NORTRIPTYLINE ASSAY
Syva Co.
LFG
May 2, 1986K861155EMIT DESIPRAMINE ASSAY
Syva Co.
LFG
Aug 12, 1985K853113TD TRICYCLIC ANTIDEPRESSANTS
Abbott Laboratories
LFG
Jun 28, 1985K844953EMIT DESIPRAMINE ASSAY
Syva Co.
LFG
Jun 28, 1985K844952EMIT NORTRIPTYLINE ASSAY
Syva Co.
LFG
Jun 28, 1985K844951EMIT IMIPRAMINE ASSAY
Syva Co.
LFG
Jun 28, 1985K844950EMIT AMITRIPTYLINE ASSAY
Syva Co.
LFG
May 2, 1984K841532ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES
E.I. Dupont DE Nemours & Co., Inc.
LFG
Mar 19, 1984K834550EMIT ST SERUM TRICYCLIC ANTIDEPRESSANT
Syva Co.
LFG
Aug 11, 1983K831978EMIT SERUM TRICYCLIC ANTIDEPRESSENT
Syva Co.
LFG
Jul 2, 1982K821743EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY
Syva Co.
LFG
Jun 14, 1982K821653PROTRIPTYLINE TRI-CY TEST SET
Wien Laboratories, Inc.
LFG
Jun 14, 1982K821652DOXEPIN TRI-CY TEST SET
Wien Laboratories, Inc.
LFG

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