# CED: 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase

- Device class: 1; regulation: 21 CFR 862.1520; FDA's rule: 510(k) exempt
- FDA decisions: 9
- 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)
- 1979: 1
- 1980: 1
- 1981: 3
- 1982: 1
- 1984: 2
- 1989: 1

## Most-cited predicates

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