# CEK: Biuret (Colorimetric), Total Protein

- Device class: 2; regulation: 21 CFR 862.1635; FDA's rule: 510(k) exempt
- FDA decisions: 116
- Recalls: 6 (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)
- 1990: 6
- 1991: 6
- 1992: 8
- 1993: 2
- 1994: 4
- 1995: 3
- 1996: 3
- 1997: 1
- 1998: 2
- 1999: 1

## Most-cited predicates
- K853681: Sigma 610 for Protein in Urine & CSF (1985), cited by 1
- K896230: Cobas Ready Total Protein Reagent (1990), cited by 1

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