# LAN: Enzyme Immunoassay, N-Acetylprocainamide

- Device class: 2; regulation: 21 CFR 862.3320; FDA's rule: 510(k) required
- FDA decisions: 21
- 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)
- 1987: 2
- 1989: 1
- 1992: 1
- 1993: 1
- 1996: 1
- 1997: 1
- 1998: 1
- 2001: 1
- 2003: 1
- 2006: 1

## Most-cited predicates
- K830206: TDX N-Acetylprocainamide (1983), cited by 2
- K833378: N-Acetylprocainamide Aca-Analytical (1983), cited by 1
- K032564: Dimension N-Acetylprocainamide (Napa) Flex Reagent Cartridge Method, Model DF111 (2003), cited by 1
- K871680: Modified Cobas FP Reagents for Napa and Calibrator (1987), cited by 1

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