# JZJ: Prealbumin, Antigen, Antiserum, Control

- Device class: 1; regulation: 21 CFR 866.5060; FDA's rule: 510(k) exempt
- FDA decisions: 11
- 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)
- 1978: 1
- 1983: 1
- 1985: 2
- 1988: 3
- 1991: 1
- 1995: 1
- 1998: 1
- 2000: 1

## Most-cited predicates
- K884297: SPQ (TM) Test System for Prealbumin (1988), cited by 1

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