# JCM: Control, Hemoglobin, Abnormal

- Device class: 2; regulation: 21 CFR 864.7415; 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: 2
- 1991: 3
- 1992: 1
- 1993: 1
- 1994: 1
- 1995: 1
- 1999: 1
- 2001: 1
- 2005: 1

## Most-cited predicates
- K011389: Hemoglobin F & A2 Control (Beta-Thalassaemia Control) (2001), cited by 1
- K933086: Afsc Hemo Control #5331, AA2 Hemo Control #5328 (1994), cited by 1
- K983704: Modification to Abuscreen Online for Phencyclidine (1999), cited by 1

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