LFG — Radioimmunoassay, Tricyclic Antidepressant Drugs Class II
FDA product code LFG covers "Radioimmunoassay, Tricyclic Antidepressant Drugs", a Class II medical device regulated under 21 CFR 862.3910. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K844951 | syva | EMIT IMIPRAMINE ASSAY | June 28, 1985 |
| K844953 | syva | EMIT DESIPRAMINE ASSAY | June 28, 1985 |
| K844950 | syva | EMIT AMITRIPTYLINE ASSAY | June 28, 1985 |
| K844952 | syva | EMIT NORTRIPTYLINE 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 |