# MXZ: Immunohistochemistry Assay, Antibody, Progesterone Receptor

- Device class: 2; regulation: 21 CFR 864.1860; FDA's rule: 510(k) required
- FDA decisions: 13
- Recalls: 2 (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)
- 2002: 2
- 2005: 1
- 2006: 1
- 2007: 1
- 2011: 1
- 2013: 1
- 2016: 1
- 2017: 2
- 2018: 1
- 2020: 1

## Most-cited predicates
- K042884: Dakocytomation ER/PR Pharmdx Kit (2005), cited by 3
- K130861: Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-to-Use (Link) (2013), cited by 2
- K990618: Ventana PGR Primary Antibody (Clone 1A6) (1999), cited by 2
- K020023: Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for Immunoenzymatic Staining (2002), cited by 2
- K171753: BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (2017), cited by 1

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