# LAZ: N-Acetylprocainamide Control Materials

- Device class: 1; regulation: 21 CFR 862.3280; FDA's rule: 510(k) exempt
- FDA decisions: 4
- 510(k) review time 2021–2025: median 114 days (middle half 114–114)
- 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)
- 1981: 1
- 1982: 1
- 1985: 1
- 2021: 1

## Most-cited predicates

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