# KNK: Acid, Uric, Uricase (Colorimetric)

- Device class: 1; regulation: 21 CFR 862.1775; FDA's rule: 510(k) exempt
- FDA decisions: 118
- Recalls: 8 (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)
- 1996: 2
- 1997: 4
- 1998: 1
- 1999: 2
- 2001: 2
- 2002: 1
- 2003: 2
- 2004: 1
- 2007: 1
- 2011: 1

## Most-cited predicates
- K922762: Roche Reagent for Uric Acid--Modification (1992), cited by 2
- K873363: Uric Acid Pap (1987), cited by 2

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