# LFH: U.V. Spectrometry, Tricyclic Antidepressant Drugs

- Device class: 2; regulation: 21 CFR 862.3910; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 297 days (middle half 259–335)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1995: 1
- 1996: 1
- 1998: 2
- 2022: 1
- 2023: 1

## Most-cited predicates
- K983268: Modification of Tricyclic Serum Tox Eia Assay (1998), cited by 1
- K213875: DRI TM Tricyclics Serum Tox Assay (2022), cited by 1

Source page: https://510kreport.com/product-code/LFH
Data by year (CSV): https://510kreport.com/product-code/LFH.csv