# MKU: Enzyme Immunoassay, Nicotine And Nicotine Metabolites

- Device class: 1; regulation: 21 CFR 862.3220; FDA's rule: 510(k) exempt
- FDA decisions: 7
- 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)
- 1997: 1
- 1998: 2
- 2003: 1
- 2007: 1
- 2019: 1
- 2020: 1

## Most-cited predicates
- K972481: Auto-Lyte Cotinine Eia (1997), cited by 3
- K974234: Micro-Plate Cotinine Eia (1998), cited by 1
- K974534: Micro-Plate Cotinine Eia (1998), cited by 1

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