# KLB: Radioimmunoassay, Tobramycin

- Device class: 2; regulation: 21 CFR 862.3900; FDA's rule: 510(k) required
- FDA decisions: 23
- 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)
- 1982: 1
- 1983: 1
- 1984: 1
- 1985: 2
- 1987: 1
- 1988: 1
- 1989: 1
- 1990: 2
- 2001: 2
- 2006: 1

## Most-cited predicates
- K003341: Emit 2000 Tobramycin Assay Emit 2000 Tobramycin Calibrators (2001), cited by 1

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