# JKD: Radioimmunoassay, C-Peptides Of Proinsulin

- Device class: 1; regulation: 21 CFR 862.1135; FDA's rule: 510(k) exempt
- FDA decisions: 10
- 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)
- 1981: 3
- 1982: 1
- 1984: 2
- 1985: 1
- 1990: 1
- 1995: 1
- 1996: 1

## Most-cited predicates
- K951848: Aia-Pack CPR Assay (1996), cited by 2

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