Product code LFG
- Device name
- Radioimmunoassay, Tricyclic Antidepressant Drugs
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3910
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Intended to measure any of the tricyclic antidepressant drugs in serum or urine.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K151348 | 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) | Healgen Scientific,, LLC | 2015-08-18 |
| K142609 | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine | Guangzhou Wondfo Biotech Co., Ltd. | 2014-12-18 |
| K112395 | WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-09 |
| K072062 | UCP MULTIPLE DRUG SCREEN TEST CUPS | Ucp Biosciences, Inc. | 2007-09-20 |
| K061457 | UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS | Ucp Biosciences, Inc. | 2006-08-21 |
| K021526 | ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE | ACON Laboratories, Inc. | 2002-07-17 |
| K011545 | VERDICT -II TCA, VERDICT-II MTD | Medtox Diagnostics, Inc. | 2001-06-08 |
| K980249 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | Princeton BioMeditech Corp. | 1998-03-13 |
| K870823 | EMIT NORTRIPTYLINE ASSAY | Syva Co. | 1987-03-20 |
| K861155 | EMIT DESIPRAMINE ASSAY | Syva Co. | 1986-05-02 |
| K853113 | TD TRICYCLIC ANTIDEPRESSANTS | Abbott Laboratories | 1985-08-12 |
| K844950 | EMIT AMITRIPTYLINE ASSAY | Syva Co. | 1985-06-28 |
| K844951 | EMIT IMIPRAMINE ASSAY | Syva Co. | 1985-06-28 |
| K844952 | EMIT NORTRIPTYLINE ASSAY | Syva Co. | 1985-06-28 |
| K844953 | EMIT DESIPRAMINE ASSAY | Syva Co. | 1985-06-28 |
| K841532 | ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES | E.I. Dupont DE Nemours & Co., Inc. | 1984-05-02 |
| K834550 | EMIT ST SERUM TRICYCLIC ANTIDEPRESSANT | Syva Co. | 1984-03-19 |
| K831978 | EMIT SERUM TRICYCLIC ANTIDEPRESSENT | Syva Co. | 1983-08-11 |
| K821743 | EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY | Syva Co. | 1982-07-02 |
| K821653 | PROTRIPTYLINE TRI-CY TEST SET | Wien Laboratories, Inc. | 1982-06-14 |
| K821652 | DOXEPIN TRI-CY TEST SET | Wien Laboratories, Inc. | 1982-06-14 |
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|---|---|---|---|
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| 10612479255323 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-18 |
| 10612479258430 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-18 |
| 10694644100140 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
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