# MJX: Kit, Serological, Positive Control

- Device class: 1; regulation: 21 CFR 862.1660; FDA's rule: 510(k) exempt
- FDA decisions: 7
- 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)
- 1993: 1
- 1994: 1
- 1997: 3
- 2003: 1
- 2010: 1

## Most-cited predicates
- K030067: Vitros Immunodiagnostic Products Hbsag Controls (2003), cited by 1

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