LFG — Radioimmunoassay, Tricyclic Antidepressant Drugs Class II
Classification Details
- Product Code
- LFG
- Device Class
- Class II
- Regulation Number
- 862.3910
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Definition
Intended to measure any of the tricyclic antidepressant drugs in serum or urine.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K151348 | healgen scientific | Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptylin | August 18, 2015 |
| K142609 | guangzhou wondfo biotech co | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine | December 18, 2014 |
| K112395 | guangzhou wondfo biotech co | WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST | September 9, 2011 |
| K072062 | ucp biosciences | UCP MULTIPLE DRUG SCREEN TEST CUPS | September 20, 2007 |
| K061457 | ucp biosciences | UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS | August 21, 2006 |
| K021526 | acon laboratories | ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE | July 17, 2002 |
| K011545 | medtox diagnostics | VERDICT -II TCA, VERDICT-II MTD | June 8, 2001 |
| K980249 | princeton biomeditech | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | March 13, 1998 |
| K870823 | syva | EMIT NORTRIPTYLINE ASSAY | March 20, 1987 |
| K861155 | syva | EMIT DESIPRAMINE ASSAY | May 2, 1986 |
| K853113 | abbott laboratories | TD TRICYCLIC ANTIDEPRESSANTS | August 12, 1985 |
| K844952 | syva | EMIT NORTRIPTYLINE ASSAY | June 28, 1985 |
| K844953 | syva | EMIT DESIPRAMINE ASSAY | June 28, 1985 |
| K844950 | syva | EMIT AMITRIPTYLINE ASSAY | June 28, 1985 |
| K844951 | syva | EMIT IMIPRAMINE ASSAY | June 28, 1985 |
| K841532 | e.i. dupont de nemours and co | ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES | May 2, 1984 |
| K834550 | syva | EMIT ST SERUM TRICYCLIC ANTIDEPRESSANT | March 19, 1984 |
| K831978 | syva | EMIT SERUM TRICYCLIC ANTIDEPRESSENT | August 11, 1983 |
| K821743 | syva | EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY | July 2, 1982 |
| K821653 | wien laboratories | PROTRIPTYLINE TRI-CY TEST SET | June 14, 1982 |