# LKA: Culture Media, Antimicrobial Susceptibility Test

- Device class: 2; regulation: 21 CFR 866.1700; FDA's rule: 510(k) required
- FDA decisions: 5
- Recalls: 4 (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)
- 1983: 2
- 1987: 3

## Most-cited predicates

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