# DOE: Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

- Device class: 2; regulation: 21 CFR 862.3640; FDA's rule: 510(k) required
- FDA decisions: 12
- 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)
- 1983: 2
- 1987: 2
- 1988: 1
- 1994: 2
- 1995: 1
- 2000: 1
- 2001: 3

## Most-cited predicates
- K951319: Roche Abuscreen Online for Opiates 1000 Test Kit-2000 NG/ML Cutoff Olympus AU800 Instrument Application (1995), cited by 1

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