# LRM: Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

- Device class: 2; regulation: 21 CFR 866.5100; FDA's rule: 510(k) required
- FDA decisions: 29
- Recalls: 3 (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: 3
- 1997: 2
- 1998: 4
- 1999: 1
- 2000: 3
- 2004: 1
- 2006: 1
- 2009: 1
- 2010: 1

## Most-cited predicates
- K950031: Varelisa Dsdna Antibodies (Farr Version) (1995), cited by 2
- K993727: Bindazyme Anti-Dsdna Eia Kit (1999), cited by 1

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