# DKN: Radioimmunoassay, Barbiturate

- Device class: 2; regulation: 21 CFR 862.3150; FDA's rule: 510(k) required
- FDA decisions: 4
- 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
- 1983: 1
- 1988: 1
- 1991: 1

## Most-cited predicates
- K881816: Abuscreen (R) Ontrak (TM) for Barbiturates (1988), cited by 2
- K914468: Abuscreen (R) Online (TM) for Barbiturates (1991), cited by 1

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