# MLM: Enzyme Immunoassay, Tracrolimus

- Device class: 2; regulation: 21 CFR 862.1678; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 758 days (middle half 758–758)
- Recalls: 8 (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)
- 1999: 2
- 2001: 1
- 2002: 2
- 2005: 1
- 2006: 2
- 2007: 2
- 2013: 1
- 2015: 1
- 2018: 1
- 2023: 1

## Most-cited predicates
- P970007: Imx Tacrolimus II Assay (1997), cited by 5
- K070820: Architect Tacrolimus: Model 1L77 (2007), cited by 4
- K063868: Masstrak Immunosuppressants Kit (2007), cited by 1

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