# KLQ: Radioimmunoassay, Amikacin

- Device class: 2; regulation: 21 CFR 862.3035; FDA's rule: 510(k) required
- FDA decisions: 20
- 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)
- 1981: 1
- 1982: 4
- 1983: 1
- 1984: 3
- 1985: 1
- 1989: 1
- 1990: 1
- 1996: 1
- 2004: 1
- 2005: 1

## Most-cited predicates
- K852317: Cobas FP Reagen for Amikacin & Amikacin Calibrator (1985), cited by 1
- K802669: Cybrex Amikacin (1980), cited by 1

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