# JCN: Control, Cell Counter, Normal And Abnormal

- Device class: 2; regulation: 21 CFR 864.8625; FDA's rule: 510(k) exempt
- FDA decisions: 12
- 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)
- 1982: 1
- 1987: 1
- 1989: 3
- 1990: 3
- 1991: 1
- 1993: 1
- 1994: 1
- 1999: 1

## Most-cited predicates
- K911582: Stak-Chex (1991), cited by 2
- K934497: CBC-STK (TM) Hematology Control/Multiple (1993), cited by 1
- K901875: Para 12 Plus (1990), cited by 1
- K993825: Para Tech Plus Retics (1999), cited by 1
- K896154: Para Tech for Technicon H-1 (1989), cited by 1
- K902389: Tri-Count 16 (1990), cited by 1

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