LFH — U.V. Spectrometry, Tricyclic Antidepressant Drugs Class II
FDA Device Classification
Classification Details
- Product Code
- LFH
- Device Class
- Class II
- Regulation Number
- 862.3910
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K231020 | microgenics corporation | Alinity c Tricyclic Antidepressants Reagent Kit | November 17, 2023 |
| K213875 | microgenics corporation | DRI TM Tricyclics Serum Tox Assay | December 21, 2022 |
| K983268 | diagnostic reagents | MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY | November 18, 1998 |
| K981801 | princeton biomeditech | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | August 25, 1998 |
| K961393 | diagnostic reagents | TRICYCLICS SERUM TOX ASSAY | June 12, 1996 |
| K953761 | abbott laboratories | AXSYM TRICYCLIC ANTIDEPRESSANTS | November 22, 1995 |