# LNJ: Analyzer, Chromosome, Automated

- Device class: 2; regulation: 21 CFR 864.5260; FDA's rule: 510(k) required
- FDA decisions: 11
- 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)
- 1985: 2
- 1986: 1
- 1987: 2
- 1990: 2
- 1991: 1
- 1995: 1
- 2001: 1
- 2005: 1

## Most-cited predicates
- K012103: Bandview System (2001), cited by 3
- K940240: Ikaros (1995), cited by 1
- K050236: Fishview (2005), cited by 1
- K902311: Genevision - Computer Assisted Chromosome Karyo. (1990), cited by 1

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