# KHW: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

- Device class: 2; regulation: 21 CFR 866.3220; FDA's rule: 510(k) exempt
- FDA decisions: 18
- 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)
- 1985: 3
- 1986: 2
- 1987: 1
- 1988: 1
- 1989: 2
- 1990: 1
- 1995: 1
- 1996: 2
- 1999: 1
- 2017: 1

## Most-cited predicates
- K994101: E. Histolytica II (1999), cited by 1

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