# LKQ: Antibody Igm,If, Cytomegalovirus Virus

- Device class: 2; regulation: 21 CFR 866.3175; FDA's rule: 510(k) required
- FDA decisions: 18
- 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)
- 1987: 2
- 1988: 2
- 1989: 2
- 1990: 1
- 1991: 1
- 1992: 1
- 1993: 1
- 1994: 1
- 1997: 1
- 2010: 1

## Most-cited predicates
- K933549: Vidas CMV Igm Assay (1994), cited by 2

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