# DEH: Lambda, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5550; FDA's rule: 510(k) required
- FDA decisions: 53
- Recalls: 4 (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)
- 1995: 4
- 1996: 8
- 1997: 11
- 2000: 1
- 2001: 3
- 2003: 2
- 2004: 1
- 2009: 1
- 2014: 1
- 2018: 1

## Most-cited predicates
- K031016: Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring Nephelometer II (2003), cited by 6
- K023131: Freelite Human Lambda Free Kit (2003), cited by 1
- K896918: Mouse Anti-Human Leucocyte Antigen & Dako Pap Kit (1990), cited by 1
- K924726: Dako Mouse Anti-Human B-Cell (Dako-C020-L26 Mono Anti (1994), cited by 1
- K965022: Monoclonal Mouse Anti-Human CD30, KI-1 Antigen, Ber-H2 Antibody for Immunoenzymatic Staining (Product Code NO. MO751) (1997), cited by 1

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