# LPJ: Kit, Assay, Estrogen Receptor

- Device class: 3; regulation: 21 CFR 864.1860; FDA's rule: PMA required
- FDA decisions: 4
- 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)
- 1981: 2
- 1982: 3
- 1983: 1
- 1984: 1
- 1985: 3
- 1986: 1
- 1988: 3
- 1992: 2
- 1995: 1
- 1999: 1

## Most-cited predicates
- P880026: Abbott ER-Ica Monoclonal (1988), cited by 2

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