# LIN: Antisera, Conjugated Fluorescent, Cytomegalovirus

- Device class: 2; regulation: 21 CFR 866.3175; FDA's rule: 510(k) required
- FDA decisions: 17
- Recalls: 0 (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)
- 1985: 1
- 1986: 1
- 1989: 3
- 1990: 1
- 1991: 2
- 1992: 1
- 1994: 1
- 1996: 2
- 1999: 2
- 2008: 1

## Most-cited predicates
- K951550: CMV Brite Antigenemia Test Kit (1996), cited by 2
- K951821: Cytomegalovirus Direct Immunofluorescence Assay (1996), cited by 1
- K921616: CMV-Vue (TM) CMV Antigen Detection Kit (1992), cited by 1
- K904036: Bartels Cytomegalovirus Immed. Early Antigen (1990), cited by 1

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