# MYA: Immunohistochemistry Antibody Assay, Estrogen Receptor

- Device class: 2; regulation: 21 CFR 864.1860; FDA's rule: 510(k) required
- FDA decisions: 12
- 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)
- 1999: 1
- 2000: 1
- 2002: 2
- 2006: 2
- 2009: 1
- 2012: 1
- 2013: 1
- 2014: 1
- 2017: 1
- 2018: 1

## Most-cited predicates
- K993957: Dako Monoclonal Mouse Anti-Human Estrogen Receptor (2000), cited by 2
- K984567: Ventana ER Primary Antibody (Clone 6F11) (1999), cited by 2
- K120663: Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone Epi (2013), cited by 2
- K060227: Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11) (2006), cited by 1
- K012138: Modification to Acis (Automated Cellular Imaging System) (2002), cited by 1
- K081286: Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634 (2009), cited by 1

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