# LCQ: Fluorescent Immunoassay Gentamicin

- Device class: 2; regulation: 21 CFR 862.3450; FDA's rule: 510(k) required
- FDA decisions: 19
- 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)
- 1982: 1
- 1984: 2
- 1985: 3
- 1989: 1
- 1990: 1
- 1991: 1
- 1994: 1
- 1995: 1
- 1996: 1
- 1997: 1

## Most-cited predicates
- K904226: 'Tdxflx Analyzer (1990), cited by 6
- K843827: Cobas Reagents for Gentamicin & Calibrat (1985), cited by 1
- K945523: Cobas (R)-FP Reagents for Gentamicin and Cobas (R)-FP Gentamicin Calibrators (1995), cited by 1

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