# MHI: Giardia Spp.

- Device class: 2; regulation: 21 CFR 866.3220; FDA's rule: 510(k) exempt
- FDA decisions: 27
- Recalls: 5 (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)
- 1994: 1
- 1995: 3
- 1996: 3
- 1998: 2
- 1999: 1
- 2002: 1
- 2003: 4
- 2009: 1
- 2011: 1
- 2013: 1

## Most-cited predicates
- K983399: Giardia/Cryptosporidium Combo Rapid Assay (1999), cited by 3
- K912408: Merifluor-Cryptosporidium/Giardia (1991), cited by 3
- K031942: Xpect Giardia Lateral Flow Assay, Model 2450020 (2003), cited by 2
- K955157: Prospect Giardia/Cryptosporidium Microplate Assay (1996), cited by 1
- K033274: Giardia II (2003), cited by 1

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