# ORH: Lamotrigine Assay

- Device class: 2; regulation: 21 CFR 862.3350; FDA's rule: 510(k) required
- FDA decisions: 2
- Recalls: 0 (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)
- 2007: 1
- 2010: 1

## Most-cited predicates
- K062966: QMS Lamotrigine Assay (Reagents), Calibrators & Controls (2007), cited by 1

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