# LJC: Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

- Device class: 1; regulation: 21 CFR 866.3120; FDA's rule: 510(k) required
- FDA decisions: 67
- Recalls: 7 (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)
- 1991: 6
- 1992: 7
- 1993: 1
- 1994: 1
- 1995: 3
- 1996: 3
- 1997: 2
- 1998: 1
- 2003: 1
- 2004: 2

## Most-cited predicates
- K951010: Chlamydia Oia (1995), cited by 1

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