# JKR: Radioimmunoassay, Calcitonin

- Device class: 2; regulation: 21 CFR 862.1140; FDA's rule: 510(k) required
- FDA decisions: 20
- Recalls: 1 (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)
- 1995: 2
- 1996: 1
- 1997: 1
- 1998: 1
- 1999: 1
- 2002: 1
- 2006: 1
- 2013: 1
- 2018: 1
- 2026: 1

## Most-cited predicates
- K132828: Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3 (2013), cited by 2
- K964635: Nichols Advantage Chemiluminescence Calcitonin Kit (1997), cited by 1
- K023304: Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCL (2002), cited by 1

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