# LJP: Antiserum, Fluorescent, Chlamydia Trachomatis

- Device class: 1; regulation: 21 CFR 866.3120; FDA's rule: 510(k) required
- FDA decisions: 35
- 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)
- 1982: 1
- 1983: 2
- 1984: 4
- 1985: 5
- 1986: 6
- 1987: 9
- 1988: 3
- 1990: 3
- 1994: 1
- 2007: 1

## Most-cited predicates
- K895839: Pathodx Chlamydia Culture Confirmation PKCC1 (1990), cited by 1
- K864663: Pathfinder Chlamydia Culture Confirmation System (1987), cited by 1
- K864389: Chlamydiae Flourescent Monoclonal Antibody Test (1986), cited by 1

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