Atlas FDA

LFG

21 FDA 510(k) clearances · Product code

52 daysmedian time to decision
190 days90th percentile
21clearances measured

FDA profile

Official device name
Radioimmunoassay, Tricyclic Antidepressant Drugs
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3910
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
FDA definition
Intended to measure any of the tricyclic antidepressant drugs in serum or urine.
Adverse events (MAUDE)
2000: 2 · 2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
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,, LLC2015-08-18
CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine (K142609)Guangzhou Wondfo Biotech Co., Ltd.2014-12-18
WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST (K112395)Guangzhou Wondfo Biotech Co., Ltd.2011-09-09
UCP MULTIPLE DRUG SCREEN TEST CUPS (K072062)Ucp Biosciences, Inc.2007-09-20
UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS (K061457)Ucp Biosciences, Inc.2006-08-21
ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE (K021526)ACON Laboratories, Inc.2002-07-17
VERDICT -II TCA, VERDICT-II MTD (K011545)Medtox Diagnostics, Inc.2001-06-08
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (K980249)Princeton BioMeditech Corp.1998-03-13
EMIT NORTRIPTYLINE ASSAY (K870823)Syva Co.1987-03-20
EMIT DESIPRAMINE ASSAY (K861155)Syva Co.1986-05-02
TD TRICYCLIC ANTIDEPRESSANTS (K853113)Abbott Laboratories1985-08-12
EMIT IMIPRAMINE ASSAY (K844951)Syva Co.1985-06-28
EMIT DESIPRAMINE ASSAY (K844953)Syva Co.1985-06-28
EMIT AMITRIPTYLINE ASSAY (K844950)Syva Co.1985-06-28
EMIT NORTRIPTYLINE ASSAY (K844952)Syva Co.1985-06-28
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES (K841532)E.I. Dupont DE Nemours & Co., Inc.1984-05-02
EMIT ST SERUM TRICYCLIC ANTIDEPRESSANT (K834550)Syva Co.1984-03-19
EMIT SERUM TRICYCLIC ANTIDEPRESSENT (K831978)Syva Co.1983-08-11
EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY (K821743)Syva Co.1982-07-02
PROTRIPTYLINE TRI-CY TEST SET (K821653)Wien Laboratories, Inc.1982-06-14
DOXEPIN TRI-CY TEST SET (K821652)Wien Laboratories, Inc.1982-06-14

Track LFG automatically

Every clearance here is in the API, with alerts when new ones post.