# LCR: Fluorescent Immunoassay, Tobramycin

- Device class: 2; regulation: 21 CFR 862.3900; 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)
- 1982: 4
- 1983: 1
- 1984: 1
- 1985: 1
- 1986: 1
- 1991: 2
- 1995: 1
- 1996: 1
- 1998: 1
- 2006: 1

## Most-cited predicates
- K802668: Cybrex Tobramycin (1980), cited by 2
- K962818: Tobramycin Flex Reagent Cartridge (1996), cited by 1

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