# LFW: Fluorescence Polarization Immunoassay, Tobramycin

- Device class: 2; regulation: 21 CFR 862.3900; FDA's rule: 510(k) required
- FDA decisions: 10
- Recalls: 2 (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)
- 1984: 1
- 1985: 2
- 1987: 1
- 1989: 1
- 1990: 1
- 1991: 1
- 1994: 2
- 1997: 1

## Most-cited predicates
- K912143: Cedia (R) Tobramycin Assay (1991), cited by 1
- K843828: Cobas Reagents for Tobramycin & Calibra (1985), cited by 1
- K941614: Axsym Tobramycin (1994), cited by 1

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